Type 2 Diabetes Mellitus, Coronary Atherosclerosis
Conditions
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.
Interventions
DRUGiobitridol
Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.
Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
Sponsors
Guerbet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | 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% |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Included Patients All patients included in the study. | 348 |
| Total | 348 |
Baseline characteristics
| Characteristic | All Included Patients |
|---|---|
| Age, Continuous | 60.18 years STANDARD_DEVIATION 6.48 |
| Sex: Female, Male Female | 212 Participants |
| Sex: Female, Male Male | 136 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 328 | 0 / 328 | 0 / 328 |
| other Total, other adverse events | 8 / 328 | 12 / 328 | 7 / 328 |
| serious Total, serious adverse events | 0 / 328 | 0 / 328 | 0 / 328 |
Outcome results
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intention To Treat Population | Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus | 23 Participants |
95% CI: [0.043, 0.1]
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%
Time frame: From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intention To Treat Population | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | No stenosis: 0% | 80 Participants |
| Intention To Treat Population | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | Non-significant stenosis: 1-50% | 152 Participants |
| Intention To Treat Population | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | Significant stenosis: >50% and ≤99% | 61 Participants |
| Intention To Treat Population | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | Occlusion: 100% | 6 Participants |
| Patients With at Least One Occult Myocardial Scar | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | Occlusion: 100% | 1 Participants |
| Patients With at Least One Occult Myocardial Scar | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | No stenosis: 0% | 2 Participants |
| Patients With at Least One Occult Myocardial Scar | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | Significant stenosis: >50% and ≤99% | 12 Participants |
| Patients With at Least One Occult Myocardial Scar | Number of Patients With and Without Occult Myocardial Scar on Cardiac MRI According to the Degree of Stenosis | Non-significant stenosis: 1-50% | 8 Participants |