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

NCT ID: NCT01254552

Last Updated: 2019-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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

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Type 2 Diabetes Mellitus Coronary Atherosclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Dotarem and Xenetix 350

Group Type EXPERIMENTAL

iobitridol

Intervention Type DRUG

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

Intervention Type DRUG

Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Interventions

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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.

Intervention Type DRUG

gadoterate meglumine

Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)

Intervention Type DRUG

Other Intervention Names

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Xenetix gadoteric acid Dotarem

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guerbet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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ISO-44-011

Identifier Type: -

Identifier Source: org_study_id

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