Back to resultsAssessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis (ACCREDIT)
Primary Purpose
Type 2 Diabetes Mellitus, Coronary Atherosclerosis
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
iobitridol
gadoterate meglumine
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dotarem and Xenetix 350
Arm Description
Outcomes
Primary Outcome Measures
Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus
Secondary Outcome Measures
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
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%
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01254552
Brief Title
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Acronym
ACCREDIT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guerbet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Coronary Atherosclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
351 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dotarem and Xenetix 350
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
iobitridol
Other Intervention Name(s)
Xenetix
Intervention Description
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
Intervention Name(s)
gadoterate meglumine
Other Intervention Name(s)
gadoteric acid, Dotarem
Intervention Description
Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis
Description
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%
Time Frame
From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
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