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NCT06419894Not yet recruiting

Advanced Cardiac Magnetic Resonance Imaging for Assessment of Obstructive Coronary Artery Disease: ADVOCATE-CMR

Source: ClinicalTrials.gov · Last updated 13 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
182 (estimated)
First submitted
3 May 2024
Start date
1 Dec 2024
Primary completion date
1 Jun 2033
Lead sponsor
Amsterdam UMC, location VUmc
NCT number
NCT06419894

What you commit to

  • Study type: Observational
  • Planned participants: 182
  • From 1 Dec 2024 to the primary completion date, 1 Jun 2033
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent or prior (within last 30 days) participation in other research studies using interventional drugs

Other illness

  • 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)
  • Allergic reaction to iodized contrast
  • 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)

Lab values

  • 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)

Other

  • Use of sildenafil or dipyridamole that cannot be terminated
  • Pregnancy or lactation

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.