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

Study Overview
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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.

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus, Coronary Atherosclerosis

Intervention / Treatment
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* Drug: iobitridol
* Drug: gadoterate meglumine


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotarem and Xenetix 350<br> | Drug: iobitridol<br>* Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.<br>* Other names: Xenetix;Drug: gadoterate meglumine<br>* Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)<br>* Other names: Dotarem;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 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) |