Arteriosclerotic heart disease Narrowed heart arteries
Conditions
Interventions
New non-invasive CMR techniques will be compared to the golden standard invasive FFR measurement for the detection of obstructive CAD.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: ADVOCATE-CMR: - Suspected obstructive CAD - No documented prior history of CAD - Clinical referral for ICA according to the referring clinician*s decision - Age >=18 years - Signed informed consent ADVOCATE-CMR 2: - Suspected obstructive CAD - Previous myocardial infarction and/or percutaneous coronary intervention, at least 3 months earlier - Clinical referral for ICA according to the referring clinician*s decision - Age >=18 years - Signed informed consent
Exclusion criteria
Exclusion criteria: ADVOCATE-CMR: - Acute coronary syndrome - History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting surgery) - History of CAD 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 CMR with GBCA (including severe claustrophobia, MR unsafe implants/devices or MR conditional devices not suitable for 3T scanner, severe renal failure with eGFR 220/120 mmHg), systolic blood pressure 220/120 mmHg), systolic blood pressure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Diagnostic accuracy (sensitivity, specificity, accuracy, area under the curve [AUC], positive predictive value [PPV], negative predictive value [NPV]) of QP-CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by FFR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: 1) Diagnostic accuracy (sensitivity, specificity, accuracy, AUC, PPV, NPV) of stress T1 mapping reactivity to detect obstructive CAD, as defined by FFR; 2) Diagnostic accuracy (sensitivity, specificity, accuracy, AUC, PPV, NPV) of OS-CMR (B-MORE) to detect obstructive CAD, as defined by FFR; 3) Head-to-head comparison of diagnostic accuracies (sensitivity, specificity, accuracy, AUC, PPV, NPV) of QP-CMR (stress MBF, stress rMBF, MPR, rMPR), stress T1 mapping reactivity, OS-CMR (B-MORE) and conventional visual assessment of GBCA-based first pass perfusion imaging to detect obstructive CAD, as defined by FFR; 4) Diagnostic accuracy (sensitivity, specificity, accuracy, AUC, PPV, NPV) of QP-CMR (stress MBF, stress rMBF, MPR and rMPR) to detect obstructive CAD, as defined by iFR and resting Pd/Pa; 5) Diagnostic accuracy (sensitivity, specificity, accuracy, AUC, PPV, NPV) of stress T1 mapping reactivity to detect obstructive CAD, as defined by iFR and resting Pd/Pa; 6) Diagnostic accuracy (sensitivity, specificity, accuracy, AUC, PPV, NPV) of OS-CMR (B-MORE) to detect obstructive CAD, as defined by iFR and resting Pd/Pa; 7) Head-to-head comparison of diagnostic accuracies (sensitivity, specificity, accuracy, AUC, PPV, NPV) of QP-CMR (stress MBF, stress rMBF, MPR, rMPR), stress T1 mapping reactivity, OS-CMR (B-MORE) and conventional visual assessment of GBCA-based first pass perfusion imaging to detect obstructive CAD, as defined by iFR and resting Pd/PaRelation of stress and rest MBF and rMBF, MPR and rMPR, stress T1 mapping and B-MORE to Seattle Angina Questionnaire (SAQ)-7 Summary score, SAQ-7 Angina Frequency score, SAQ-7 Physical Limitation score and SAQ-7 Quality of Life score (before and after revascularization) and score in Rose Dyspnea Scale; 8) Prognostic value of QP-CMR (stress MBF, stress rMBF, MPR and rMPR), stress T1 mapping reactivity and OS-CMR (B-MORE) in predicting occurrence of a A) composite of cardiovascul | — |
Countries
Canada, Netherlands
Contacts
Public ContactG.W. Mooij
Amsterdam UMC
Outcome results
None listed