Non-invasive and Invasive Assessment of Coronary Artery Disease

University Medical Center Groningen120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

120

Conditions

Coronary Artery Disease

Interventions

adenosine stress Cardiac Magnetic Resonance ImagingDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

University Medical Center Groningen, Departments of Cardiology and Radiology

Groningen, Netherlands

University Hospital Linköping, Departments of Clinical Physiology, Cardiology and Center for Medial Imaging Visualization

Linköping, Sweden

Outcomes

Primary Outcomes

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.

Time frame: one month

Secondary Outcomes

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.

Time frame: one month

Data from ClinicalTrials.gov

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