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

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 - COMFORT

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39232

Enrollment

120

Registered

2011-07-15

Start date

2011-12-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

angina pectoris stable angina pectoris

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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) 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

Design outcomes

Primary

Measure	Time frame
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 will be investigated.	—

Secondary

Measure	Time frame
The ability of combined use of MSCT coronary angiography and stress CMR imaging to predict treatment strategy (medical therapy versus revascularization therapy) as compared to CAG and FFR will be determined.	—

Countries

Netherlands

Outcome results