Non-invasive and Invasive Assessment of Coronary Artery Disease

NCT01823809 | Terminated

• 1 other identifier: METc2011.084
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Computed Tomography; Cardiac Magnetic Resonance; Fractional Flow Reserve

Outcome Measures

Primary Outcomes (1)

• 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.

  one month

Secondary Outcomes (1)

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

  one month

Study Arms (1)

Imaging arm

OTHER

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

Device: adenosine stress Cardiac Magnetic Resonance Imaging

Interventions

adenosine stress Cardiac Magnetic Resonance Imaging DEVICE

Imaging arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

University Medical Center Groningen, Departments of Cardiology and Radiology

Groningen, 9700 RB, Netherlands

Location

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

Linköping, Sweden

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Gabija Pundziute, MD, PhD

  University Medical Center Groningen, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2013
• First Posted: April 4, 2013
• Study Start: November 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

NL (1); SE (1)