Clinical trial NCT01823809: Non-invasive and Invasive Assessment of Coronary Artery Disease
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Computed Tomography
Cardiac Magnetic Resonance
Fractional Flow Reserve
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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:

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.

Primary outcomes:
measure: Diagnostic accuracy to detect ischemia with stress CMR compared to FFR
timeFrame: one month
Secondary outcomes:
measure: Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy
timeFrame: one month
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Departments of Cardiology and Radiology
city: Linköping
country: Sweden
facility: University Hospital Linköping, Departments of Clinical Physiology, Cardiology and Center for Medial Imaging Visualization
Study officials:
affiliation: University Medical Center Groningen, Department of Cardiology
name: Gabija Pundziute, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: