- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06419894
Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR (ADVOCATE-CMR)
May 14, 2024 updated by: Sonia Borodzicz-Jazdzyk, Amsterdam UMC, location VUmc
Stress perfusion cardiovascular magnetic resonance (CMR) imaging is an established non-invasive imaging test for detection of obstructive coronary artery disease (CAD).
Fully automated quantitative perfusion CMR (QP CMR) is a new technical advancement, which offers measurement of myocardial blood flow in CMR.
Additionally, recent innovations have introduced various contrast-agent-free methods for CAD assessment, such as stress T1 mapping reactivity (∆T1) and oxygen-sensitive CMR (OS CMR).
These methods might eliminate the necessity for contrast administration in clinical practice, simplifying, reducing time, invasiveness and costs in evaluating patients with suspected obstructive CAD.
The ADVOCATE-CMR study aims to validate QP CMR, ∆T1 and OS CMR imaging against invasive fractional flow reserve (FFR) for detection of obstructive CAD.
The study also aims to head-to-head compare the diagnostic accuracy of these CMR techniques with the conventional visual assessment of stress perfusion CMR and to correlate them to short- and long-term clinical outcomes.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Study design: Single-center, observational, prospective, cross-sectional cohort study performed at the Amsterdam University Medical Centers - Location VUmc.
Study population: 182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography (ICA) according to the decision of the treating clinician.
Methods:
- CMR image acquisition prior to clinically scheduled ICA, using the following pulse sequences: cine imaging, OS-CMR with breathing maneuvers, adenosine-stress and rest T1 mapping, adenosine-stress and rest QP-CMR, late gadolinium enhancement;
- Fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), ratio between proximal and distal coronary pressures over entire resting cycle period (Pd/Pa ratio), coronary flow reserve (CFR) and index of microcircular resistance (IMR) in all main coronary arteries during ICA;
- Follow-up CMR according to the abovementioned protocol 3 months after ICA (or 3 months after revascularization, if performed separately more than 1 day following ICA);
- Clinical follow-up - 3, 6 months, 1 and 3 years after ICA or revascularization (if performed separately more than 1 day following ICA)
Study Type
Observational
Enrollment (Estimated)
182
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
182 symptomatic patients with suspected obstructive CAD (without a previous CAD history), scheduled for invasive coronary angiography according to the decision of the treating clinician.
Description
Inclusion criteria:
- Suspected obstructive coronary artery disease
- No documented prior history of coronary artery disease
- Clinical referral for invasive coronary angiography according to the referring clinician's decision
- Competent adult (age ≥18 years)
- Signed informed consent
Exclusion criteria:
- Acute coronary syndrome
- History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting surgery)
- History of coronary artery disease or acute coronary syndrome (myocardial infarction, unstable angina)
- Use of sildenafil or dipyridamole that cannot be terminated
- Pregnancy or lactation
- Allergic reaction to iodized contrast
- Concurrent or prior (within last 30 days) participation in other research studies using interventional drugs
- Extensive comorbidities (i.e. cancer, other severe chronic diseases)
- Contraindication for cardiac magnetic resonance with gadolinium-based contrast agent (including severe claustrophobia, magnetic resonance unsafe implants/devices or MR conditional devices not suitable for 3T scanner, severe renal failure with estimated glomerular filtration rate<30 mL/min/1,73 m2, known hypersensitivity for gadolinium-based contrast agent)
- Contraindications for adenosine usage (including hypersensitivity to adenosine/dipyridamole/regadenoson, second or third degree atrio-ventricular block, sick sinus syndrome, sinus bradycardia (heart rate <40 bpm), long QT syndrome, severe hypertension (> 220/120 mmHg), systolic blood pressure <90mmHg, concomitant use of dipyridamole, severe asthma or severe chronic obstructive pulmonary disease)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of QP CMR (stress myocardial blood flow [MBF], stress relative MBF [rMBF], myocardial perfusion reserve [MPR] and relative MPR [rMPR]) to detect obstructive CAD, as defined by FFR
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, area under the curve (AUC), positive predictive value (PPV), negative predictive value (NPV)
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Diagnostic accuracy of OS CMR (breathing-induced myocardial oxygenation reserve; B-MORE) to detect obstructive CAD, as defined by FFR
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of GBCA-based first pass perfusion imaging to detect obstructive CAD, as defined by FFR
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Diagnostic accuracy of OS CMR (B-MORE) to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Head-to-head comparison of diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR, rMPR), ΔT1, OS CMR (B-MORE) and conventional visual assessment of first pass perfusion imaging to detect obstructive CAD, as defined by iFR and resting Pd/Pa
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score
Time Frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
|
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Angina Frequency score
Time Frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
|
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Physical Limitation score
Time Frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
|
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Quality of Life score
Time Frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
|
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Rose Dyspnea Scale score
Time Frame: Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)
|
|
Prognostic value of QP CMR (stress MBF, stress rMBF, MPR and rMPR), stress T1 mapping reactivity and OS CMR (B-MORE)
Time Frame: 3 months, 6 months, 1 year, 3 years
|
|
3 months, 6 months, 1 year, 3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic accuracies of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ΔT1 and B-MORE to detect microvascular dysfunction (MVD), as defined by CFR
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Diagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR), ΔT1 and B-MORE to differentiate between MVD (as defined by CFR) and 3-vessel obstructive CAD
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Sensitivity, specificity, accuracy, AUC, PPV, NPV
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Change in stress MBF after revascularization
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Difference between stress MBF before revascularization (baseline) and after revascularization (in ml/g/min)
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Change in MPR after revascularization
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Difference between MPR before revascularization (baseline) and after revascularization
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Change in stress T1 mapping after revascularization
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Difference between stress T1 mapping before revascularization (baseline) and after revascularization (in ms)
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Change in ΔT1 after revascularization
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Difference between ΔT1 before revascularization (baseline) and after revascularization
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Change in B-MORE after revascularization
Time Frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Difference between B-MORE before revascularization (baseline) and after revascularization (in %)
|
ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Costs of QP CMR, stress T1 mapping reactivity and OS CMR compared to ICA
Time Frame: CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
|
Procedural time of QP CMR, stress T1 mapping reactivity and OS CMR compared to ICA
Time Frame: CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
CMR and following ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2024
Primary Completion (Estimated)
June 1, 2033
Study Completion (Estimated)
June 1, 2033
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 14, 2024
First Posted (Actual)
May 17, 2024
Study Record Updates
Last Update Posted (Actual)
May 17, 2024
Last Update Submitted That Met QC Criteria
May 14, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL84828.015.23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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