Non-invasive and Invasive Assessment of Coronary Artery Disease

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01823809

Acronym

COMFORT

Enrollment

120

Registered

2013-04-04

Start date

2011-11-30

Completion date

2016-10-31

Last updated

2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, Computed Tomography, Cardiac Magnetic Resonance, Fractional Flow Reserve

Brief 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.

Interventions

DEVICEadenosine stress Cardiac Magnetic Resonance Imaging

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy to detect ischemia with stress CMR compared to FFR	one month	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.

Secondary

Measure	Time frame	Description
Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy	one month	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.

Countries

Netherlands, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026