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

Guerbet351 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

351

Conditions

Type 2 Diabetes Mellitus Coronary Atherosclerosis

Interventions

iobitridolDRUG

Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.

gadoterate meglumineDRUG

Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus

Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Secondary Outcomes

Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis

The degree of coronary artery stenosis on CCTA was assessed according to the following scale: * No stenosis: 0% * Non significant stenosis: 1-50% * Significant stenosis \>50% and ≤99% * Occlusion: 100%

Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Data from ClinicalTrials.gov

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