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

February 14, 2019 updated by: Guerbet

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dotarem and Xenetix 350
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.
Other Names:
  • Xenetix
Drug: gadoterate meglumine
Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
Other Names:
  • Dotarem
  • gadoteric acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
Time Frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
Time Frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guerbet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

December 3, 2010

First Posted (Estimate)

December 6, 2010

Study Record Updates

Last Update Posted (Actual)

May 31, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISO-44-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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