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

NCT01254552 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2019-05-31

Study results available
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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).

Conditions

Interventions

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)

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-09-30
Completion
2016-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254552 on ClinicalTrials.gov