Non-invasive and Invasive Assessment of Coronary Artery Disease (COMFORT)

University Medical Center Groningen (UMCG)

Status: Terminated

Conditions: Coronary Artery Disease

Treatments: Device: adenosine stress Cardiac Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01823809

METc2011.084

Details and patient eligibility

About

The purpose of the study is to assess the diagnostic accuracy of a combined use of non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions on MSCT and with low to intermediate pre-test likelihood of coronary artery disease (CAD) as compared to invasive coronary angiography (CAG) and Fractional Flow Reserve (FFR) measurements.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with stable angina pectoris with low to intermediate pre-test likelihood of CAD;
2. no previous history of CAD;
3. obstructive stenosis (≥50% luminal narrowing) on MSCT coronary angiography; 4.informed consent.

Exclusion criteria

1. patients with a previous history of CAD;
2. patients with contraindications for MSCT: a.cardiac rhythms other than sinus rhythm, b.pregnancy, c.allergy for contrast medium, d.renal failure (estimated glomerular filtration rate (eGFR) < 50ml/min), e.resting heart rate >75 bpm plus contra-indications for beta-blockade, f. weight >100 kilograms;
3. contraindications for cardiac magnetic resonance (CMR) imaging: a.MR-incompatible implants, b. Claustrophobia, c. contraindications for adenosine: i. known or suspected hypersensitivity to adenosine, ii. known or suspected bronchoconstrictive or bronchospastic disease, iii. 2nd or 3rd degree atrioventricular (AV) block, iv. Sinus bradycardia (heart rate < 45 bpm), v. Systemic arterial hypotension (<90 mmHg). d. contraindications for gadolinium: i. renal failure (estimated eGFR <30 ml/min);
4. no informed consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Imaging arm

Other group

Description:

There is one study arm only. The imaging modalities will be performed in all patients.

Treatment:

Device: adenosine stress Cardiac Magnetic Resonance Imaging