Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis (ACCREDIT)

Guerbet

Status and phase

Completed

Phase 4

Conditions

Coronary Atherosclerosis

Type 2 Diabetes Mellitus

Treatments

Drug: iobitridol

Drug: gadoterate meglumine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01254552

ISO-44-011

Details and patient eligibility

About

The study aimed to prospectively investigate the prevalence of myocardial scar on Dotarem-enhanced Cardiovascular Magnetic Resonance Imaging (MRI) in asymptomatic patients with type-2 Diabetes Mellitus and to assess its correlation with subclinical coronary artery disease on Cardiac Computed Tomography Angiography (CCTA).

Full description

Patients underwent a cardiac MRI examination with Dotarem within 60 days after screening visit. The myocardial CCTA examination with Xenetix 350 was performed within 1 to 30 days (but no sooner than 24 hours) after the MRI examination.

Enrollment

351 patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient with onset of type 2 diabetes occurred at age 30 years or older
Patient between the ages of 50 and 75 years at enrolment time
Patient with at least two identified cardiac risk factors who will undergo a CMR and a CCTA examinations to evaluate his/her coronary and cardiac status

Exclusion criteria

Patient with angina pectoris or chest discomfort
Patient with stress test or invasive coronary angiography within the prior 3 years
Patient with history of myocardial infarction, overt non compensated heart failure, or coronary revascularization
Patient with hemodynamic instability.
Patient with a contraindication or intolerance to Beta-Blocker administration