Coronary InsufficiencyPhase 4MRDiabeticsNCT00797082
Magnetic Resonance Diabetic Cardiac Stress Imaging
A Phase 4 study testing MRI and MPS in people with Coronary Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to assess the efficacy of cardiac MRI to detect coronary disease in diabetic patients. Cardiac MRI will be compared to myocardial scintigraphy with is the method being used in current practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Insufficiency
- What is being tested?
- MRI and MPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Jul 2012
- Phase
- Phase 4
- 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
- Patient older than 18 years old
- Patient with health care coverage ( social security or universal health coverage - CMU)
- Patient who had a prior medical examination
- Diabetic patient (type 1 or type 2) with no known coronary artery disease, addressed for myocardial scintigraphy
- Patient who was informed of objectives and constraints of the study and having given his consent in writing
Who cannot join
- Pregnant and lactating women
- Patients with known coronary disease (myocardial infarction, unstable angina, history of coronary artery disease)
- Patient with contra-indication for MRI claustrophobia, metallic foreign body in the eye, pacemakers, mechanical heart valve laid before 1985 Patient with specific contra-indication to vasodilators
- Severe hypotension < 90 mmHg
- Hypersensitivity to adenosine or dipyridamole
- Bronchial asthma, chronic obstructive pulmonary disease with obvious bronchospasm. Severe and known pulmonary artery hypertension
Show all 14Show fewer
- Atrioventricular 2nd or 3rd degree blocks, long QT syndrome
- Tight known carotid artery stenosis (70% NASCET criterion), with no possible vascular substitution
- Patient with contra-indication to cardiac stimulation
- Unstable hemodynamic state and / or unstable angina not stabilized by drug treatment and/or decompensated or severe heart failure
- Known comorbidities : pregnancy and lactation, tight aortic valve or mitral valve stenosis, severe left-right shunt, severe pericarditis or abundant pericardial effusion
- Contra-indication to coronary angiography
- Renal failure with creatinine clearance < 30 ml / min
- Hypersensitivity to contrast agents that resulted in a serious complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Diabetic Cardiac Stress Imaging : MRDIABETICS
The aim of the study is to assess the efficacy of cardiac MRI to detect coronary disease in diabetic patients. Cardiac MRI will be compared to myocardial scintigraphy with is the method being used in current practice. The investigators believe that cardiac MRI will be as efficient if not better that myocardial scintigraphy to detect tight coronary artery stenosis with the advantage of providing no radiation to the patient. Moreover, the investigators believe that cardiac MR will add additional information regarding possible undetected myocardial infarction.
Read the detailed description
Rationale:
The incidence of diabetes is rising constantly. According to the WHO projections, the population of diabetics will double by 2025. In France, the current population of diabetics is estimated at 2.5 millions persons. The cause of death in diabetics involves a cardiovascular condition in approximately 65-80% of the cases. The leading event is myocardial infarction. The prevalence of silent myocardial ischemia (SMI) in diabetics varies widely from 10 to 30%. The prognosis of SMI is closely dependent on the presence or not of angiographically significant coronary artery stenosis - CAS (patients with SMI and CAS>70% show 31% of major cardiac events at 41±24 months vs only 1.4% in patients with SMI and no CAS>70%). It seems therefore important to identify diabetic patients with SMI and CAS especially knowing that endovascular or surgical treatments are available and can potentially improve the prognosis of such patients.
Myocardial Perfusion Scintigraphy (MPS) is widely prescribed to detect coronary stenosis. It has a high sensitivity (90%) but an intermediate specificity (75%), providing a significant amount of false positive cases. Such false positive cases are usually followed with unnecessary coronary angiographies. Myocardial Perfusion Stress MRI (MRI) has been recently developed and shows promising preliminary results (equivalent sensitivity, higher specificity compared to MPS) for the identification of coronary artery stenosis. Few studies directly compare MRI and MPS in the general population, none in the diabetic population.
Principal objective: To evaluate and compare diagnostic performances of MRI and MPS for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease.
Secondary objective:
- Cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease.
- Impact of clinical information on MRI and MPS diagnostic performances.
Design:. Prospective, monocentric study, where MRI and MPS will be assessed in a centralised manner by 2 independent blinded readers (2 readers for each technique) and compared to coronary angiography (Gold Standard, assessed by 2 independent blinded readers).
Patient selection: Patient with diabetes (type 1 or type 2), free of known coronary disease, addressed for MPS.
Inclusion period length: 24 months
Follow up period length: 2 days
Principal judgement criteria:
Coronary angiography: positive diagnosis of CAS if stenosis >50% on the left coronary artery (trunk) or stenosis >70% on the IVA (inter ventricular artery), LCx (circumflex artery) or RCA (right coronary artery) and branches.
MPS : positive diagnosis of CAS based on the following criteria : severity perfusion index, reversibility, contractility anomalies, signal attenuation due to patient morphology.
MRI : positive diagnosis of CAS based on an algorithm including the following criteria : first pass perfusion defect at stress, reversibility at rest, Myocardial Delayed Enhancement.
Number of necessary patients: 165
Expected results: An assessment of MRI performances compared to MPS for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease that will help improve diagnostic strategy.
- Conditions
- Coronary Insufficiency
- Being tested
- MRI, MPS
- Keywords
- Diabetic, Coronary disease, Atherosclerosis, Magnetic resonance imaging, Myocardial Perfusion Scintigraphy, Coronary angiography
- Medical subject headings
- Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MRI = Myocardial Perfusion Stress
MPSDevice
MPS = Myocardial Perfusion Scintigraphy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MRI = Myocardial Perfusion Stress and MPS = Myocardial Perfusion Scintigraphy
* Diabetic patients
* Coronary insufficiency Receives: Device: MRI; Device: MPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive diagnosis of coronary artery disease.
Measured: 2 days
Secondary outcomes (1)
cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2011
- Study completionJul 2012
Why it stopped: default of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary InsufficiencyStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Michel SERFATY, PHU, Principal investigator, ASSISTANCE PUBLIQUE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797082
- Sponsor's protocol ID
- P070149
- Other IDs
- AOR07022
- Acronym
- MRDiabetics
- Status last verified
- Jul 2012
- First submitted
- 27 Oct 2008
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Diabetic Cardiac Stress Imaging : MRDIABETICS
- ClinicalTrials.gov ID
- NCT00797082
- Acronym / sponsor ID
- MRDiabetics / P070149
- Conditions
- Coronary Insufficiency
- Keywords
- Diabetic, Coronary disease, Atherosclerosis, Magnetic resonance imaging, Myocardial Perfusion Scintigraphy, Coronary angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: default of inclusion
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 Nov 2008 (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 aim of the study is to assess the efficacy of cardiac MRI to detect coronary disease in diabetic patients. Cardiac MRI will be compared to myocardial scintigraphy with is the method being used in current practice. The investigators believe that cardiac MRI will be as efficient if not better that myocardial scintigraphy to detect tight coronary artery stenosis with the advantage of providing no radiation to the patient. Moreover, the investigators believe that cardiac MR will add additional information regarding possible undetected myocardial infarction.
Detailed description
Rationale:
The incidence of diabetes is rising constantly. According to the WHO projections, the population of diabetics will double by 2025. In France, the current population of diabetics is estimated at 2.5 millions persons. The cause of death in diabetics involves a cardiovascular condition in approximately 65-80% of the cases. The leading event is myocardial infarction. The prevalence of silent myocardial ischemia (SMI) in diabetics varies widely from 10 to 30%. The prognosis of SMI is closely dependent on the presence or not of angiographically significant coronary artery stenosis - CAS (patients with SMI and CAS>70% show 31% of major cardiac events at 41±24 months vs only 1.4% in patients with SMI and no CAS>70%). It seems therefore important to identify diabetic patients with SMI and CAS especially knowing that endovascular or surgical treatments are available and can potentially improve the prognosis of such patients.
Myocardial Perfusion Scintigraphy (MPS) is widely prescribed to detect coronary stenosis. It has a high sensitivity (90%) but an intermediate specificity (75%), providing a significant amount of false positive cases. Such false positive cases are usually followed with unnecessary coronary angiographies. Myocardial Perfusion Stress MRI (MRI) has been recently developed and shows promising preliminary results (equivalent sensitivity, higher specificity compared to MPS) for the identification of coronary artery stenosis. Few studies directly compare MRI and MPS in the general population, none in the diabetic population.
Principal objective: To evaluate and compare diagnostic performances of MRI and MPS for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease.
Secondary objective:
- Cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease.
- Impact of clinical information on MRI and MPS diagnostic performances.
Design:. Prospective, monocentric study, where MRI and MPS will be assessed in a centralised manner by 2 independent blinded readers (2 readers for each technique) and compared to coronary angiography (Gold Standard, assessed by 2 independent blinded readers).
Patient selection: Patient with diabetes (type 1 or type 2), free of known coronary disease, addressed for MPS.
Inclusion period length: 24 months
Follow up period length: 2 days
Principal judgement criteria:
Coronary angiography: positive diagnosis of CAS if stenosis >50% on the left coronary artery (trunk) or stenosis >70% on the IVA (inter ventricular artery), LCx (circumflex artery) or RCA (right coronary artery) and branches.
MPS : positive diagnosis of CAS based on the following criteria : severity perfusion index, reversibility, contractility anomalies, signal attenuation due to patient morphology.
MRI : positive diagnosis of CAS based on an algorithm including the following criteria : first pass perfusion defect at stress, reversibility at rest, Myocardial Delayed Enhancement.
Number of necessary patients: 165
Expected results: An assessment of MRI performances compared to MPS for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease that will help improve diagnostic strategy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: MRI, Device: MPSMRI = Myocardial Perfusion Stress and MPS = Myocardial Perfusion Scintigraphy * Diabetic patients * Coronary insufficiency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient older than 18 years old
- Patient with health care coverage ( social security or universal health coverage - CMU)
- Patient who had a prior medical examination
- Diabetic patient (type 1 or type 2) with no known coronary artery disease, addressed for myocardial scintigraphy
- Patient who was informed of objectives and constraints of the study and having given his consent in writing
Key exclusion criteria (14 listed)
- Pregnant and lactating women
- Patients with known coronary disease (myocardial infarction, unstable angina, history of coronary artery disease)
- Patient with contra-indication for MRI claustrophobia, metallic foreign body in the eye, pacemakers, mechanical heart valve laid before 1985 Patient with specific contra-indication to vasodilators
- Severe hypotension < 90 mmHg
- Hypersensitivity to adenosine or dipyridamole
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 |
|---|---|---|
| MRIMRI = Myocardial Perfusion Stress | Device | 1 |
| MPSMPS = Myocardial Perfusion Scintigraphy | Device | 1 |
Primary outcome
positive diagnosis of coronary artery disease.
Time frame: 2 days
1 secondary outcome
cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease
Time frame: 26 months
Results and safety
The study was stopped early (reason given: default of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
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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.
Jean Michel SERFATY, PHU principal investigator
ASSISTANCE PUBLIQUE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MRI and MPS in people with Coronary Insufficiency, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 14 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 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: default of inclusion). 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?
positive diagnosis of coronary artery disease. (time frame: 2 days). 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 31 Jul 2012.