Phase 4
N=351
Assessment With CCTA and MRI in Asymptomatic Patients With Type 2 Diabetes for Detection of Unrecognized Myocardial Scar in Subclinical Coronary Atherosclerosis
Type 2 Diabetes Mellitus · Coronary Atherosclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01254552 ↗Enrolled (actual)
351
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus — 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- iobitridol (Drug); gadoterate meglumine (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Guerbet
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus |
23 | — |
| SECONDARY Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis |
80; 2; 152; 8; 61; 12 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT01254552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.