NCT01254552

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Coronary Atherosclerosis

Interventions

Type	Name	Description
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.
DRUG	gadoterate meglumine	Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-09-01
• Completion: 2016-10-01
• First posted: 2010-12-06
• Last updated: 2019-05-31
• Results posted: 2019-05-31

Locations

1 site across 1 country: South Korea