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Clinical Trials/NL-OMON56707
NL-OMON56707Not yet recruitingNot Applicable

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 - ADVOCATE-CMR and ADVOCATE-CMR 2

Amsterdam UMC0 sites302 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
302

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18 to 99 (—)

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
  • - 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
  • - 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
  • - 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)

Investigators

Sponsor
Amsterdam UMC

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