Advanced Cardiac Magnetic Resonance imaging for assessment of Obstructive Coronary Artery disease: ADVOCATE-CMR; Advanced Cardiac Magnetic Resonance imaging for assessment of Obstructive Coronary Artery disease in patients with prior CAD: ADVOCATE-CMR 2

• Conditions: Arteriosclerotic heart disease; narrowed heart arteries; 10011082

• Registration Number: NL-OMON56707
• Lead Sponsor: Amsterdam UMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 302

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

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<30 mL/min/1,73 m2, known hypersensitivity for
GBCA)
- 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)

ADVOCATE-CMR 2:
- Acute coronary syndrome
- History of coronary artery bypass grafting surgery
- 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<30 mL/min/1,73 m2, known hypersensitivity for
GBCA)
- 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 & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: Diagnostic accuracy (sensitivity, specificity, accuracy, area<br /><br>under the curve [AUC], positive predictive value [PPV], negative predictive<br /><br>value [NPV]) of QP-CMR (stress MBF, stress rMBF, MPR and rMPR) to detect<br /><br>obstructive CAD, as defined by FFR.</p><br>