Myocardial IschemiaNCT02723747
Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
An observational study of Myocardial Ischemia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia
- What is being tested?
- myocardial perfusion with magnetic resonance imaging
- How many people
- 66 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2016to Dec 2023
- 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: Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).
Who may be able to join
- healthy individuals with normal 12-lead electrocardiogram at rest.
Who cannot join
- systolic blood pressure below 90 mmHg;
- bradycardia (< 45 heart beats/minute);
- intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination;
- impaired renal function assessed by venous blood sample.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Molecular Medicine and Surgery, Karolinska Institutet
Stockholm, 171 76
About this study
The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.
Read the detailed description
Cardiac magnetic resonance (CMR) imaging is a wide available technique for the diagnosis of myocardial ischemia. However, myocardial first-pass perfusion evaluation has been limited due to the moderate accuracy of the currently available qualitative and semiquantitative methods used to assess myocardial perfusion, and due to the lack of efficient absolute quantitative methods. Some CMR techniques and post-processing mathematical models have been developed for quantitative measurement of myocardial blood flow reserve with perfusion CMR under pharmacological stress. Measurement of these parameters with CMR have been shown to increase the accuracy of CMR in diagnosing myocardial ischemia, but most of these methods present technical challenges and have unreasonably time consuming post-processing. The aim of this study is to validate a full automated post-processing software for first pass perfusion CMR images that results in automated generated quantitative perfusion color maps.
- Conditions
- Myocardial Ischemia
- Being tested
- myocardial perfusion with magnetic resonance imaging
- Keywords
- myocardial ischemia, magnetic resonance imaging, perfusion, software
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myocardial perfusion with magnetic resonance imagingOther
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Healthy subjects with normal 12-lead electrocardiogram at rest. Receives: Other: myocardial perfusion with magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g)
Measured: Through study completion, an average of 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2018
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Ugander, Karolinska Institutet
- Investigators
- Martin Ugander, MD, PhD, Principal investigator, Department of Molecular Medicine and Surgery, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723747
- Sponsor's protocol ID
- QUACK
- Status last verified
- Jun 2022
- First submitted
- 16 Mar 2016
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Nickander J, Themudo R, Thalen S, Sigfridsson A, Xue H, Kellman P, Ugander M. The relative contributions of myocardial perfusion, blood volume and extracellular volume to native T1 and native T2 at rest and during adenosine stress in normal physiology. J Cardiovasc Magn Reson. 2019 Nov 25;21(1):73. doi: 10.1186/s12968-019-0585-9.
PubMed 31767018
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Myocardial Perfusion Reserve by Cardiovascular Magnetic Resonance
- ClinicalTrials.gov ID
- NCT02723747
- Acronym / sponsor ID
- QUACK
- Conditions
- Myocardial Ischemia
- Keywords
- myocardial ischemia, magnetic resonance imaging, perfusion, software
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Mar 2018 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Mar 2016 (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 validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.
Detailed description
Cardiac magnetic resonance (CMR) imaging is a wide available technique for the diagnosis of myocardial ischemia. However, myocardial first-pass perfusion evaluation has been limited due to the moderate accuracy of the currently available qualitative and semiquantitative methods used to assess myocardial perfusion, and due to the lack of efficient absolute quantitative methods. Some CMR techniques and post-processing mathematical models have been developed for quantitative measurement of myocardial blood flow reserve with perfusion CMR under pharmacological stress. Measurement of these parameters with CMR have been shown to increase the accuracy of CMR in diagnosing myocardial ischemia, but most of these methods present technical challenges and have unreasonably time consuming post-processing. The aim of this study is to validate a full automated post-processing software for first pass perfusion CMR images that results in automated generated quantitative perfusion color maps.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Other: myocardial perfusion with magnetic resonance imagingHealthy subjects with normal 12-lead electrocardiogram at rest. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).
Key inclusion criteria (1 listed)
- healthy individuals with normal 12-lead electrocardiogram at rest.
Key exclusion criteria (4 listed)
- systolic blood pressure below 90 mmHg;
- bradycardia (< 45 heart beats/minute);
- intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination;
- impaired renal function assessed by venous blood sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myocardial perfusion with magnetic resonance imaging | Other | Healthy volunteers |
Primary outcome
Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g)
Time frame: Through study completion, an average of 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Derived from this study: PubMed 31767018Nickander J, Themudo R, Thalen S, Sigfridsson A, Xue H, Kellman P, Ugander M. The relative contributions of myocardial perfusion, blood volume and extracellular volume to native T1 and native T2 at rest and during adenosine stress in normal physiology. J Cardiovasc Magn Reson. 2019 Nov 25;21(1):73. doi: 10.1186/s12968-019-0585-9.
- Individual participant dataSharing planned: No
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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.
Martin Ugander, MD, PhD principal investigator
Department of Molecular Medicine and Surgery, Karolinska Institutet
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 Myocardial Ischemia, run by Karolinska Institutet at 1 site in Sweden.
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 4 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: status not confirmed, as of the sponsor's last update on 8 Jun 2022. 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 Sweden. 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?
Results are not available in the source record.
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?
Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g) (time frame: Through study completion, an average of 9 months). 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 NCT02723747, which also lists 1 linked publication.
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 8 Jun 2022.