Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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]
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06419894 · NL84828.015.23