AzTrials
AzTrials

Myocardial Perfusion ImagingPhase 2NCT01490294

Myocardial Perfusion MRI

A Phase 2 study testing Gadobutrol (Gadavist,Gadovist, BAY86-4875) in people with Myocardial Perfusion Imaging and Magnetic Resonance Imaging, run by Bayer at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
14 sitesin 4 countries
Study dates
Mar 2004to May 2006
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females of any ethnic group with reversible focal hypoperfusion in at least 2 adjoining segments in SPECT
  • The SPECT examination had been performed within 4 weeks prior to the MRI examination and had been performed for clinical reasons only

Who cannot join

  • Generalized myocardial hypoperfusion (e.g. severe 3 vessel disease)
  • Recent myocardial infarction (MI) (within 1 week prior to the study procedure)
  • Event that significantly altered cardiac performance between SPECT and MRI imaging, e.g. myocardial infarction, unstable angina, alteration of cardiac medication
  • Non-sinus rhythm
  • Sinus node disease or symptomatic bradycardia
  • Second or third degree atrial ventricular (AV) block
Show all 16Show fewer
  • Complete left bundle branch block (LBBB)
  • Known congenital long QT syndrome or a family history of congenital long QT syndrome
  • Known previous arrhythmias on drugs that prolong cardiac repolarization
  • Uncorrected hypokalemia
  • Uncontrolled hypertension (e.g. systolic blood pressure >185 mm Hg, diastolic blood pressure >110 mm Hg)
  • Baseline hypotension (e.g. mean arterial pressure <60 mm Hg)
  • Ejection fraction below 35%
  • Cardiomyopathy, congenital heart defect or higher degree valvular pathology
  • Coronary artery stent placement within 4 weeks prior to the MRI procedure
  • Previous heart transplantation

Trial locations and contacts

14 sites in 4 countries.

14 sites in 4 countries

Germany10 sites

  • Study site

    Bad Oeynhausen, North Rhine-Westphalia, 32545

  • Study site

    Berlin, 10115

  • Study site

    Bonn, North Rhine-Westphalia, 53127

  • Study site

    Essen, North Rhine-Westphalia, 45138

  • Study site

    Frankfurt am Main, Hesse, 60389

  • Study site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Study site

    München, Bavaria, 81377

  • Study site

    München, Bavaria, 81675

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

  • Study site

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Switzerland2 sites

  • Study site

    Basel, Canton of Basel-City, 4031

  • Study site

    Lugano, Canton Ticino, CH-6900

Other trials in Switzerland

Austria1 site

  • Study site

    Pölten, 3100

Other trials in Austria

Poland1 site

  • Study site

    Krakow, 31202

Other trials in Poland

About this study

Official title: Multicenter, Double Blind, Randomized Dose Finding Study in Myocardial Perfusion MRI With Gadavist®1.0

The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality.

For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body weight are administered. A study participant receives the respective dose twice i.e. at rest and at stress using Adenosine (which puts circulation into a state of stress similar to that of physical exercise). The time between both injections is 10-15 min.

The total imaging time is about 45 min.

Being tested
Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Keywords
Cardiac MRI, gadobutrol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gadobutrol (Gadavist,Gadovist, BAY86-4875)Drug

    0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg)

  • Gadobutrol (Gadavist,Gadovist, BAY86-4875)Drug

    0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg)

  • Gadobutrol (Gadavist,Gadovist, BAY86-4875)Drug

    0.05 mmol/kg BW (0.05 mL/kg) for stress MRI and 0.05 mmol/kg BW (0.05 mL/kg) for rest MRI (total dose 0.1 mmol/kg)

  • Gadobutrol (Gadavist,Gadovist, BAY86-4875)Drug

    0.1 mmol/kg BW (0.1 mL/kg) for stress MRI and 0.1 mmol/kg BW (0.1 mL/kg) for rest MRI (total dose 0.2 mmol/kg)

Study groups in NCT01490294
Study groupRoleWhat they receive
Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Receives: Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Receives: Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Receives: Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)
Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)ExperimentalParticipants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
Receives: Drug: Gadobutrol (Gadavist,Gadovist, BAY86-4875)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions

    Rest and stress perfusion Magnetic Resonance (MR) images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (left anterior decendent [LAD], left circumflex [LCX], right coronary artery [RCA]). Data were compared to the corresponding regional data from Single Photon Emission Computer Tomography (SPECT). The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  2. Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Secondary outcomes (55)

  1. Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence of cardiac perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  2. Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by the respective investigator for presence/absence of cardiac perfusion deficits in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  3. Diagnosis 'Scar': Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis Scar Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "scar" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of 'scar'. The number of regional assessments is defined as the number of regions with diagnosis 'scar' assessed by at least 1 blinded reader.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  4. Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "scar" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "scar". The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by at least 1 blinded reader.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  5. Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "scar" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "scar". The number of regional assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  6. Diagnosis "Scar": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis "Scar" Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "scar" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to the corresponding segmental SPECT diagnosis of "scar". The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  7. Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "ischemia".The number of regional assessments is defined as the number of regions with diagnosis "ischemia" assessed by at least 1 blinded reader.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  8. Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "ischemia". The number of segmental assessments is defined as the number of segments with diagnosis "ischemia" assessed by at least 1 blinded reader.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  9. Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in the 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to the corresponding regional SPECT diagnosis of "ischemia". The number of regional assessments is defined as the number of regions with diagnosis "ischemia" assessed by the investigator.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  10. Diagnosis "Ischemia": Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding the Diagnosis of Ischemia Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for presence/absence and characterization of cardiac perfusion deficits as "ischemia" in 16 myocardial segments (defined according to the American Heart Association). These data were compared to corresponding segmental SPECT diagnosis of "ischemia". The number of segmental assessments is defined as the number of segments with diagnosis "ischemia" assessed by the investigator.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  11. Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both, Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  12. Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  13. Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Regions

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or mixture of both in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  14. Percentage Agreement Between Gadobutrol Perfusion MRI (Clinical Evaluation) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Cardiac Perfusion Deficits i.e. Scar, Ischemia or a Mixture of Both Based on Myocardial Segments

    Rest and stress perfusion MR images were evaluated by the respective clinical investigator for detailed characterization of cardiac perfusion deficits i.e. scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association).MR data were compared to the corresponding segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  15. Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Regions

    Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both, in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MR data were compared to the corresponding regional data from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  16. Percent Agreement Between Combined Gadobutrol Perfusion MRI (Perfusion Imaging and Delayed (DE) Imaging; Blinded Reading) and SPECT (Central Reading) Regarding a Detailed Diagnosis of Perfusion Deficits Based on Myocardial Segments

    Rest and stress perfusion and DE MR images were evaluated by 3 independent blinded readers regarding the detailed characterization of cardiac perfusion deficits i.e scar, ischemia or a mixture of both in 16 myocardial segments (defined according to the American Heart Association). MR data were compared to the corresponding segmental data derived from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  17. Percentage of Artifacts in Gadobutrol Perfusion MRI (Blinded Reading) Based on Myocardial Segments

    Rest and stress MR images were evaluated by 3 independent blinded readers regarding the presence/absence of artifacts in 16 myocardial segments (according to the American Heart Association). The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  18. Percentage of Artifacts in Gadobutrol Perfusion MRI (Clinical Evaluation) Based on Myocardial Segments

    Rest and stress MR images were evaluated by the investigator regarding the presence/absence of artifacts in 16 myocardial segments (defined according to the American Heart Association). The number of segments with artifacts was calculated by multiplication of the number of participants with the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  19. Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading, Based on Myocardial Regions) and Coronary Angiography (Central Reading) Regarding Detection of Significant Stenoses

    Rest and stress perfusion MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion deficits in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). These data were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of > 70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  20. Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI) " (Expert Evaluation) and Detection of Significant Stenoses by Coronary Angiography (MR Based on Myocardial Regions)

    MPRI was calculated for the upslope of the signal intensity /time curve on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). The upslope-value at post-stress was divided by the value at rest. MPRI <=1.5 (perfusion defect) and >1.5 (normal) were compared to coronary angiography regarding presence/absence of significant coronary artery stenosis of >70%. The number of regional assessments was calculated by multiplication of the number of participants with the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  21. Percentage Agreement Between Gadobutrol Perfusion MRI (Blinded Reading) and the Truth Panel Diagnosis (SoT) Regarding Perfusion Defects Based on Regions

    For patients undergoing coronary angiography additionally to SPECT, a Truth Panel with 2 cardiology experts was employed as SoT to come to a consensus diagnosis. Rest and stress MR images were evaluated by 3 independent blinded readers for presence/absence of perfusion defects in 3 myocardial regions representing the 3 arterial territories/arteries of the heart. These data were compared to the SoT diagnosis. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  22. Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Regions

    MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were compared to presence/absence of perfusion defects in the regional data analysis from SPECT. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  23. Percentage Agreement Between the Semiquantitative Gadobutrol Perfusion MRI Parameter "Myocardial Perfusion Reserve Index (MPRI)" (Expert Evaluation) and SPECT (Central Reading) Based on Myocardial Segments

    MPRI was calculated as decribed in outcome measure 22 on stress and rest perfusion MR images by an independent MR expert for 16 myocardial segments (defined according to the American Heart Association). MPRIs <= 1.5 (perfusion defect) and >1.5 (normal) were then compared to presence/absence of perfusion defects in the segmental data from SPECT. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  24. Percentage Agreement Between the Visual (Blinded Reading) and the Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Regions

    Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA): Visual and semiquantitative data were compared to each other per region. The number of regional assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial regions.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  25. Percentage Agreement Between the Visual (Blinded Reading) and Semiquantitative (MPRI; Expert Evaluation) Gadobutrol Perfusion MRI Diagnosis Based on Myocardial Segments

    Rest and stress perfusion MR images were visually evaluated by 3 blinded readers. The MPRI was calculated by an independent MR expert. Analysis was performed for 16 myocardial segments (defined according to the American Heart Association). Visual and semiquantitative data were compared to each other per segment. The number of segmental assessments was calculated by multiplication of the number of participants with the number of the blinded readers and the number of the myocardial segments.

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  26. Signal Intensity (SIrel) Based on Segments

    The signal intensity (SIrel) is determined over time. SI (SIrel) is the upslope in myocardium divided by upslope of the ventricle, as assessed for normal and underperfused segments. SI(rel) = upslope myocard / upslope ventricle. MR segments were evaluated for signal intensity (SIrel) in order to assess if a difference between normal and diseased (i.e. ischemia/scar/mixed) segments could be demonstrated ("normal/diseased" was defined by central reading of SPECT).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  27. Upslope Based on Segments

    "Upslope" is defined as the maximum slope of the signal intensity (SI) increase on the SI/time curve (determined by a linear fit) during 3 consecutive heart beats reported in "Units/sec". The upslope was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference ("normal/diseased" was defined by central reading of SPECT).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  28. Time to Peak Based on Segments

    "Time to peak" is defined as the time in seconds from start to maximum signal intensity (SI max) on the SI curve and was evaluated for normal and for diseased (i.e. ischemia/scar/mixed) segments in order to assess a potential difference (normal/diseased was defined by central reading of SPECT).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration up to 2 minutes

  29. Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Regions

    Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by 3 independent blinded readers for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 arterial territories of the heart. DE data were compared to the diagnosis "scar" derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis "scar" assessed by at least 1 blinded reader.

    Measured: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

  30. Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Blinded Reading) and Scar in SPECT (Central Reading) Based on Myocardial Segments

    Delayed enhancement -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by 3 independent blinded readers regarding the presence/absence of DE at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis "scar" derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by at least 1 blinded reader.

    Measured: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

  31. Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Regions

    Delayed enhancement (DE) -[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points, were evaluated by the clinical investigator for presence/absence of DE at 5 - 20 minutes post injection in 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA). DE data were compared to the diagnosis "scar" derived from SPECT. The number of regional assessments is defined as the number of regions with diagnosis "scar" assessed by the investigator.

    Measured: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

  32. Percentage Agreement Between Presence/Absence of Delayed Enhancement in MRI (Clinical Evaluation) and Scar in SPECT (Central Reading) Based on Myocardial Segments

    Delayed enhancement (DE)-[accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions]- MR images acquired at different time points were evaluated by the respective investigator regarding the presence/absence of delayed enhancement at 5 - 20 minutes post injection in 16 myocardial segments (defined according to the American Heart Association). DE data were compared to the diagnosis "scar" derived from SPECT. The number of segmental assessments is defined as the number of segments with diagnosis "scar" assessed by the investigator.

    Measured: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

  33. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Results are displayed on a per patient basis.

    Measured: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

  34. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

  35. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized

    Measured: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

  36. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 10 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

  37. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

    Measured: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

  38. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 15 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

  39. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

    Measured: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

  40. Assessment of the Overall Confidence in the Presence of Delayed Enhancement (DE) at 20 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

  41. Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

    Measured: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

  42. Assessment of Contrast Quality of Delayed Enhancement (DE) at 5 Minutes Post Injection (Clinical Evaluation) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 5 minutes after Gadobutrol bolus administration

  43. Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection (Blinded Reading) (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

    Measured: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

  44. Assessment of Contrast Quality of Delayed Enhancement (DE) at 10 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 10 minutes after Gadobutrol bolus administration

  45. Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

    Measured: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

  46. Assessment of Contrast Quality of Delayed Enhancement (DE) at 15 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 15 minutes after Gadobutrol bolus administration

  47. Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Blinded Reading (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Assessments of participants and/or segments by the individual blinded readers could differ. For the average reader, the results of the 3 individual readers are summarized.

    Measured: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

  48. Assessment of Contrast Quality of Delayed Enhancement (DE) at 20 Minutes Post Injection According to Clinical Evaluation (Only Participants With DE in at Least One Segment, PPS)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 20 minutes after Gadobutrol bolus administration

  49. Percent Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  50. Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Blinded Reading) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by 3 blinded readers for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  51. Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and the Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Segments

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 16 myocardial segments (defined according to AHA).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  52. Percentage Agreement Between Gadobutrol Perfusion MRI Diagnosis (Clinical Evaluation) and Presence/Absence of Delayed Enhancement (DE) at the Time Point of Highest Agreement Between SPECT (Central Reading) and DE Based on Myocardial Regions

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions. Rest and stress perfusion MR and DE images were evaluated by the clinical investigator for absence/presence of "scar" on perfusion MR and presence/absence of DE on MR for 3 myocardial regions representing the 3 coronary territories/arteries (LAD, LCX, RCA).

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

  53. Percentage of Segments With Artifacts on Delayed Enhancement Images (Blinded Reading)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

  54. Percentage of Segments With Artifacts on Delayed Enhancement Images (Clinical Evaluation)

    Delayed enhancement: accumulation of Gadobutrol in infarcted tissue and visualized as Gadobutrol enhanced regions.

    Measured: Delayed enhancement was measured at 5, 10, 15, and 20 minutes after Gadobutrol bolus administration

  55. Percentage of Participants With Deviation of MRI Procedure (Clinical Evaluation)

    Measured: Immediately within approximately 5 seconds after Gadobutrol bolus administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2011 (estimated)
  2. Study startMar 2004
  3. Primary completionMay 2006
  4. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01490294
Sponsor's protocol ID
91054
Other IDs
305501, 2005-005158-32, 2005
Status last verified
May 2014
First submitted
28 Jul 2011
Last updated
22 May 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gadobutrol (Gadavist,Gadovist, BAY86-4875) in people with Myocardial Perfusion Imaging and Magnetic Resonance Imaging, run by Bayer at 14 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, Switzerland, Austria, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Agreement Between Gadobutrol Perfusion Magnetic Resonance Imaging (MRI) (Blinded Reading) and SPECT (Central Reading) Regarding the Diagnosis for Detection of Cardiac Perfusion Deficits Based on Myocardial Regions (time frame: Immediately within approximately 5 seconds after Gadobutrol bolus administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01490294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2014.

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