Coronary Artery DiseaseNCT00758654
Strain-Encoded Cardiac Magnetic Resonance Imaging for Dobutamine Stress Testing
An observational study of Coronary Artery Disease, run by Heidelberg University at 1 site in Germany.
Trial summary
The purpose of this study is to compare the diagnostic value of SENC to that provided by conventional wall motion analysis for the detection of inducible ischemia during DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible for the diagnosis of coronary artery disease (CAD) in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2007to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients with suspected or known coronary artery disease and healthy volunteers serving as a contol group.
Who may be able to join
- Suspected or known coronary artery disease
Who cannot join
- General contraindication for a dobutamine stress or for an MRI examination
- Age < 18 yrs
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Heidelberg, Department of Cardiology
Heidelberg, 69120
About this study
Official title: Strain-Encoded Cardiac Magnetic Resonance Imaging as an Adjunct for Dobutamine Stress Testing.
The purpose of this study is to compare the diagnostic value of SENC to that provided by conventional wall motion analysis for the detection of inducible ischemia during DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible for the diagnosis of coronary artery disease (CAD) in humans. However, the assessment of cine scans relies on the visual interpretation of regional wall motion, which is subjective. Recently, Strain-Encoded MRI (SENC) has been proposed for the direct color-coded visualization of myocardial strain.
Read the detailed description
The assessment of inducible regional wall motion abnormalities during high-dose dobutamine stress magnetic resonance imaging (DS-MRI) is an established clinical method with high diagnostic and prognostic value for the evaluation of patients with coronary artery disease (CAD). However, the assessment of cine images relies on the visual interpretation of regional wall motion, which is subjective, and objective approaches for the detection of inducible ischemia with DS-MRI are still lacking.
In our study Strain-Encoded-MRI (SENC) is used for the objective color-coded evaluation of regional myocardial strain during DS-MRI in patients with intermediate to high pretest probability for CAD. We anticipated that this technique would exhibit enhanced sensitivity for the detection of anatomically significant CAD compared to conventional wall motion reading, with invasive coronary angiography used as the standard reference.
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial strain, Strain-Encoded MRI, dobutamine stress MRI, ischemia, strain rate reserve
- Medical subject headings
- Coronary Artery Disease, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with suspected or known stable coronary artery disease | |
| 2 | Healthy subjects as a control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography
Measured: 3 weeks
Secondary outcomes (1)
Long-term mortality and MACE
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G. Korosoglou, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758654
- Sponsor's protocol ID
- MRI-021
- Status last verified
- Mar 2012
- First submitted
- 23 Sep 2008
- Last updated
- 30 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Korosoglou G, Gitsioudis G, Voss A, Lehrke S, Riedle N, Buss SJ, Zugck C, Giannitsis E, Osman NF, Katus HA. Strain-encoded cardiac magnetic resonance during high-dose dobutamine stress testing for the estimation of cardiac outcomes: comparison to clinical parameters and conventional wall motion readings. J Am Coll Cardiol. 2011 Sep 6;58(11):1140-9. doi: 10.1016/j.jacc.2011.03.063.
PubMed 21884952Korosoglou G, Lehrke S, Wochele A, Hoerig B, Lossnitzer D, Steen H, Giannitsis E, Osman NF, Katus HA. Strain-encoded CMR for the detection of inducible ischemia during intermediate stress. JACC Cardiovasc Imaging. 2010 Apr;3(4):361-71. doi: 10.1016/j.jcmg.2009.11.015.
PubMed 20394897
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain-Encoded Cardiac Magnetic Resonance Imaging as an Adjunct for Dobutamine Stress Testing.
- ClinicalTrials.gov ID
- NCT00758654
- Acronym / sponsor ID
- MRI-021
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial strain, Strain-Encoded MRI, dobutamine stress MRI, ischemia, strain rate reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the diagnostic value of SENC to that provided by conventional wall motion analysis for the detection of inducible ischemia during DS-MRI.High-dose dobutamine stress magnetic resonance imaging (DS-MRI) is safe and feasible for the diagnosis of coronary artery disease (CAD) in humans. However, the assessment of cine scans relies on the visual interpretation of regional wall motion, which is subjective. Recently, Strain-Encoded MRI (SENC) has been proposed for the direct color-coded visualization of myocardial strain.
Detailed description
The assessment of inducible regional wall motion abnormalities during high-dose dobutamine stress magnetic resonance imaging (DS-MRI) is an established clinical method with high diagnostic and prognostic value for the evaluation of patients with coronary artery disease (CAD). However, the assessment of cine images relies on the visual interpretation of regional wall motion, which is subjective, and objective approaches for the detection of inducible ischemia with DS-MRI are still lacking.
In our study Strain-Encoded-MRI (SENC) is used for the objective color-coded evaluation of regional myocardial strain during DS-MRI in patients with intermediate to high pretest probability for CAD. We anticipated that this technique would exhibit enhanced sensitivity for the detection of anatomically significant CAD compared to conventional wall motion reading, with invasive coronary angiography used as the standard reference.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with suspected or known stable coronary artery disease |
| 2 | – | –Healthy subjects as a control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with suspected or known coronary artery disease and healthy volunteers serving as a contol group.
Key inclusion criteria (1 listed)
- Suspected or known coronary artery disease
Key exclusion criteria (2 listed)
- General contraindication for a dobutamine stress or for an MRI examination
- Age < 18 yrs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography
Time frame: 3 weeks
1 secondary outcome
Long-term mortality and MACE
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2012.
- Derived from this study: PubMed 21884952Korosoglou G, Gitsioudis G, Voss A, Lehrke S, Riedle N, Buss SJ, Zugck C, Giannitsis E, Osman NF, Katus HA. Strain-encoded cardiac magnetic resonance during high-dose dobutamine stress testing for the estimation of cardiac outcomes: comparison to clinical parameters and conventional wall motion readings. J Am Coll Cardiol. 2011 Sep 6;58(11):1140-9. doi: 10.1016/j.jacc.2011.03.063.
- Derived from this study: PubMed 20394897Korosoglou G, Lehrke S, Wochele A, Hoerig B, Lossnitzer D, Steen H, Giannitsis E, Osman NF, Katus HA. Strain-encoded CMR for the detection of inducible ischemia during intermediate stress. JACC Cardiovasc Imaging. 2010 Apr;3(4):361-71. doi: 10.1016/j.jcmg.2009.11.015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Heidelberg University at 1 site in Germany.
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 1 inclusion and 2 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 30 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection of coronary artery disease (>50% diameter stenosis) by invasive angiography (time frame: 3 weeks). 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 NCT00758654, which also lists 2 linked publications.
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 30 Mar 2012.