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Clinical Trials/NCT01823809
NCT01823809
Terminated
Not Applicable

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

University Medical Center Groningen2 sites in 2 countries120 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
University Medical Center Groningen
Enrollment
120
Locations
2
Primary Endpoint
Diagnostic accuracy to detect ischemia with stress CMR compared to FFR
Status
Terminated
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
October 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gabija Pundziute

Principal Investigator

University Medical Center Groningen

Eligibility Criteria

Inclusion Criteria

  • Patients with stable angina pectoris with low to intermediate pre-test likelihood of CAD;
  • no previous history of CAD;
  • obstructive stenosis (≥50% luminal narrowing) on MSCT coronary angiography; 4.informed consent.

Exclusion Criteria

  • patients with a previous history of CAD;
  • 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;
  • 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);
  • no informed consent.

Outcomes

Primary Outcomes

Diagnostic accuracy to detect ischemia with stress CMR compared to FFR

Time Frame: 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 Outcomes

  • Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy(one month)

Study Sites (2)

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