Non-invasive and Invasive Assessment of Coronary Artery Disease

Coronary Artery Disease Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01823809
• Other study ID #: METc2011.084
• Status: Terminated
• Phase: N/A
• Start date: November 2011
• Est. completion date: October 2016

Study information

• Verified date: May 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• adenosine stress Cardiac Magnetic Resonance Imaging

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen, Departments of Cardiology and Radiology	Groningen
Sweden	University Hospital Linköping, Departments of Clinical Physiology, Cardiology and Center for Medial Imaging Visualization	Linköping

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Countries where clinical trial is conducted

Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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