Non-invasive and Invasive Assessment of Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging arm

There is one study arm only. The imaging modalities will be performed in all patients.

Group Type OTHER

adenosine stress Cardiac Magnetic Resonance Imaging

Intervention Type DEVICE

Interventions

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adenosine stress Cardiac Magnetic Resonance Imaging

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No