Back to resultsNon-invasive and Invasive Assessment of Coronary Artery Disease (COMFORT)
Primary Purpose
Coronary Artery Disease
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
adenosine stress Cardiac Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Computed Tomography, Cardiac Magnetic Resonance, Fractional Flow Reserve
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.
Sites / Locations
- University Medical Center Groningen, Departments of Cardiology and Radiology
- University Hospital Linköping, Departments of Clinical Physiology, Cardiology and Center for Medial Imaging Visualization
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Imaging arm
Arm Description
There is one study arm only. The imaging modalities will be performed in all patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01823809
First Posted
March 4, 2013
Last Updated
May 1, 2018
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT01823809
Brief Title
Non-invasive and Invasive Assessment of Coronary Artery Disease
Acronym
COMFORT
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
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Problems with inclusion, >80% of patients included
Study Start Date
November 2011 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Computed Tomography, Cardiac Magnetic Resonance, Fractional Flow Reserve
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Imaging arm
Arm Type
Other
Arm Description
There is one study arm only. The imaging modalities will be performed in all patients.
Intervention Type
Device
Intervention Name(s)
adenosine stress Cardiac Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
Diagnostic accuracy to detect ischemia with stress CMR compared to FFR
Description
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 Outcome Measure Information:
Title
Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabija Pundziute, MD, PhD
Organizational Affiliation
University Medical Center Groningen, Department of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Groningen, Departments of Cardiology and Radiology
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Facility Name
University Hospital Linköping, Departments of Clinical Physiology, Cardiology and Center for Medial Imaging Visualization
City
Linköping
Country
Sweden
12. IPD Sharing Statement
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Non-invasive and Invasive Assessment of Coronary Artery Disease
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