Coronary Artery DiseaseCOMFORTNCT01823809
Non-invasive and Invasive Assessment of Coronary Artery Disease
A study testing adenosine stress Cardiac Magnetic Resonance Imaging in people with Coronary Artery Disease, run by University Medical Center Groningen at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- adenosine stress Cardiac Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2011to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
University Medical Center Groningen, Departments of Cardiology and Radiology
Groningen, 9700 RB
Sweden1 site
University Hospital Linköping, Departments of Clinical Physiology, Cardiology and Center for Medial Imaging Visualization
Linköping
About this study
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
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
- Being tested
- adenosine stress Cardiac Magnetic Resonance Imaging
- Keywords
- Coronary Artery Disease, Computed Tomography, Cardiac Magnetic Resonance, Fractional Flow Reserve
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adenosine stress Cardiac Magnetic Resonance ImagingDevice
| Study group | Role | What they receive |
|---|---|---|
| Imaging arm | Other | There is one study arm only. The imaging modalities will be performed in all patients. Receives: Device: adenosine stress Cardiac Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Problems with inclusion, \>80% of patients included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabija Pundziute, University Medical Center Groningen
- Investigators
- Gabija Pundziute, MD, PhD, Principal investigator, University Medical Center Groningen, Department of Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823809
- Sponsor's protocol ID
- METc2011.084
- Acronym
- COMFORT
- Status last verified
- May 2018
- First submitted
- 4 Mar 2013
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01823809
- Acronym / sponsor ID
- COMFORT / METc2011.084
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Computed Tomography, Cardiac Magnetic Resonance, Fractional Flow Reserve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Problems with inclusion, \>80% of patients included
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging arm | Other | Device: adenosine stress Cardiac Magnetic Resonance ImagingThere is one study arm only. The imaging modalities will be performed in all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adenosine stress Cardiac Magnetic Resonance Imaging | Device | Imaging arm |
Primary outcome
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.
1 secondary outcome
Predictive value for treatment strategy of a non-invasive strategy with MSCT and stress CMR compared to an invasive strategy
Time frame: one month
Results and safety
The study was stopped early (reason given: Problems with inclusion, \>80% of patients included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabija Pundziute, MD, PhD principal investigator
University Medical Center Groningen, Department of Cardiology
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adenosine stress Cardiac Magnetic Resonance Imaging in people with Coronary Artery Disease, run by University Medical Center Groningen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Problems with inclusion, \>80% of patients included). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy to detect ischemia with stress CMR compared to FFR (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.