Non-invasive and Invasive Assessment of Coronary Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Coronary Artery Disease With Multi-Slice Computed Tomography Combined With Stress Cardiac Magnetic Resonance Imaging Compared to Coronary Angiography Combined With Fractional Flow Reserve Trial

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: adenosine stress Cardiac Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with stable angina pectoris with low to intermediate pre-test likelihood of CAD; no previous history of CAD; obstructive stenosis (≥50% luminal narrowing) on MSCT coronary angiography; 4.informed consent. Exclusion Criteria: patients with a previous history of CAD; 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; 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); no informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Imaging arm<br>There is one study arm only. The imaging modalities will be performed in all patients. | Device: adenosine stress Cardiac Magnetic Resonance Imaging<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy to detect ischemia with stress CMR compared to FFR | The diagnostic accuracy of MSCT coronary angiography in combination with stress CMR imaging as compared to invasive CAG and FFR measurement, as a standard of reference to detect obstructive and hemodynamically significant stenoses in patients with low to intermediate pre-test likelihood of CAD. | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy | to evaluate whether MSCT coronary angiography in combination with stress CMR imaging may accurately predict treatment strategy (medical therapy versus revascularization therapy) as compared to CAG and FFR in patients with low to intermediate pre-test likelihood of CAD. | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Computed Tomography, Cardiac Magnetic Resonance, Fractional Flow Reserve