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

Type 2 Diabetes Mellitus Clinical Trial

— ACCREDIT  

Official title:

Assessment With Cardiac Computed Tomography Angiography (CCTA) and Magnetic Resonance Imaging (MRI) in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254552
• Other study ID #: ISO-44-011
• Status: Completed
• Phase: Phase 4
• Start date: August 2010
• Est. completion date: October 2016

Study information

• Verified date: February 2019
• Source: Guerbet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: October 2016
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Myocardial Ischemia
• Type 2 Diabetes Mellitus

Intervention

Drug:
• iobitridol
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 meglumine
Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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%	From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)