CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 351 enrolled
Drug / intervention
iobitridol +1 moredrug
Likely dose
iobitridol 180 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01254552
NCT01254552Phase 4Completed
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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

Guerbet·interventional·Posted Dec 6, 2010·Updated May 31, 2019

In Brief

A Phase 4 clinical trial evaluating iobitridol and gadoterate meglumine for Type 2 Diabetes Mellitus and Coronary Atherosclerosis. Completed, enrolled 351 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Coronary Atherosclerosis
CountriesSouth Korea
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 6, 2010
Enrollment StartAug 1, 2010
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.6 years ago

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)