Magnetic Resonance Diabetic Cardiac Stress Imaging

Coronary Insufficiency Clinical Trial

— MRDiabetics  

Official title:

Magnetic Resonance Diabetic Cardiac Stress Imaging : MRDIABETICS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00797082
• Other study ID #: P070149
• Secondary ID: AOR07022
• Status: Terminated
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: July 29, 2012
• Start date: November 2008
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: July 2012
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

INCLUSION CRITERIA:

• 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

EXCLUSION CRITERIA:

• 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

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Insufficiency

Intervention

Device:
• MRI
MRI = Myocardial Perfusion Stress
• MPS
MPS = Myocardial Perfusion Scintigraphy

Locations

Country	Name	City	State
France	Hopital Bichat	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive diagnosis of coronary artery disease.		2 days	No
Secondary	cost efficacy analysis for the diagnosis of coronary insufficiency in diabetic patients free of known coronary disease		26 months	No