Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT06419894
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
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.
- 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:
1. 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;
2. 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;
3. 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);
4. Clinical follow-up - 3, 6 months, 1 and 3 years after ICA or revascularization (if performed separately more than 1 day following ICA)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 182
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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)
- Secondary Outcome Measures
Name Time Method Diagnostic accuracy of OS CMR (B-MORE) to detect obstructive CAD, as defined by iFR and resting Pd/Pa ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Quality of Life score 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 Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) 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 ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Angina Frequency score 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) 3 months, 6 months, 1 year, 3 years 1. Composite of cardiovascular (CV) death (death resulting from an acute myocardial infarction, sudden cardiac death, death due to heart failure, stroke, CV procedures, CV hemorrhage, other CV causes), myocardial infarction (according ESC/ACCF/AHA/WHF 4th Universal Definition of Myocardial Infarction), ischemia-driven coronary revascularization (all coronary revascularization performed in the context of myocardial infarction and those for worsening symptoms in combination with evidence of myocardial ischemia) or stroke (acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction);
2. Composite of myocardial infarction or ischemia-driven coronary revascularization;
3. Composite of cardiovascular death, stroke or myocardial infarction;
4. Myocardial infarction;
5. Ischemia-driven coronary revascularization;
6. Stroke;
7. Death from any cause;
8. CV deathDiagnostic accuracy of QP CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by iFR and resting Pd/Pa ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by iFR and resting Pd/Pa ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable) Diagnostic accuracy of OS CMR (breathing-induced myocardial oxygenation reserve; B-MORE) to detect obstructive CAD, as defined by FFR ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
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 ICA + hemodynamic measurements within 6 weeks of the initial CMR scan Sensitivity, specificity, accuracy, AUC, PPV, NPV
Relation of stress and rest MBF and rMBF, MPR and rMPR, ΔT1 and B-MORE to SAQ-7 Physical Limitation score Before ICA and 3, 6 months, 1 and 3 years after the ICA (or revascularization if applicable)