| Trial ID: | L5719 |
| Source ID: | NCT01254552
|
| Associated Drug: |
Iobitridol
|
| 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
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01254552/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Coronary Atherosclerosis
|
| Interventions: |
DRUG: iobitridol|DRUG: gadoterate meglumine
|
| Outcome Measures: |
Primary: Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus, From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations) | Secondary: 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%, From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
|
| Sponsor/Collaborators: |
Sponsor: Guerbet
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
351
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2010-08
|
| Completion Date: |
2016-10
|
| Results First Posted: |
2019-05-31
|
| Last Update Posted: |
2019-05-31
|
| Locations: |
Asan Medical Center, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT01254552
|
