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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus; Coronary Atherosclerosis
• Interventions: Drug: iobitridol; Drug: gadoterate meglumine

• Registration Number: NCT01254552
• Lead Sponsor: Guerbet

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-12-03
• Study First Posted: 2010-12-06
• Primary Completion: 2011-09
• Study Completion: 2016-10
• Results First Submitted: 2018-09-20
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-14
• Last Update Submitted: 2019-02-14
• Results First Posted: 2019-05-31
• Last Update Posted: 2019-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dotarem and Xenetix 350	gadoterate meglumine	-
Dotarem and Xenetix 350	iobitridol	-

Primary Outcome Measures

Name	Time	Method
Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus	From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Secondary Outcome Measures

Name	Time	Method
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis	From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)	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%

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of