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

Completed

Conditions: angina pectoris
stable angina pectoris
10011082

Registration Number: NL-OMON39232

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The diagnostic accuracy of MSCT coronary angiography in combination with stress<br /><br>CMR imaging as compared to invasive CAG and FFR measurement, as a standard of<br /><br>reference to detect obstructive and hemodynamically significant stenoses in<br /><br>patients with low to intermediate pre-test likelihood of CAD will be<br /><br>investigated.<br /><br><br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The ability of combined use of MSCT coronary angiography and stress CMR imaging<br /><br>to predict treatment strategy (medical therapy versus revascularization<br /><br>therapy) as compared to CAG and FFR will be determined.<br /><br><br /><br></p><br>