An observational study in Coronary Artery Disease, sponsored by Amsterdam UMC, location VUmc. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by Amsterdam UMC, location VUmc · Observational
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 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:
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 182 is below the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Amsterdam UMC, location VUmc is the lead sponsor of 302 studies on the registry; 84 are open to participants now.
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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.
Exclusion criteria:
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
Sensitivity, specificity, accuracy, area under the curve (AUC), positive predictive value (PPV), negative predictive value (NPV)
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Diagnostic accuracy of ΔT1 to detect obstructive CAD, as defined by FFR
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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)
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)
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)
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)
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)
Prognostic value of QP CMR (stress MBF, stress rMBF, MPR and rMPR), stress T1 mapping reactivity and OS CMR (B-MORE)
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 death
Time frame: 3 months, 6 months, 1 year, 3 years
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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: 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
Sensitivity, specificity, accuracy, AUC, PPV, NPV
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Change in stress MBF after revascularization
Difference between stress MBF before revascularization (baseline) and after revascularization (in ml/g/min)
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Change in MPR after revascularization
Difference between MPR before revascularization (baseline) and after revascularization
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Change in stress T1 mapping after revascularization
Difference between stress T1 mapping before revascularization (baseline) and after revascularization (in ms)
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Change in ΔT1 after revascularization
Difference between ΔT1 before revascularization (baseline) and after revascularization
Time frame: ICA + hemodynamic measurements within 6 weeks of the initial CMR scan
Change in B-MORE after revascularization
Difference between B-MORE before revascularization (baseline) and after revascularization (in %)
Time frame: 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
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
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Amsterdam UMC, location VUmc