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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dotarem and Xenetix 350 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iobitridol | Drug | Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration. |
|
| 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) |
| 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:
| From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dotarem and Xenetix 350 | All patients were planned to undergo a MRI examination with Dotarem and a myocardial CCTA examination with Xenetix 350 to evaluate his/her coronary and cardiac status. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening Visit |
|
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|
| gadoterate meglumine | Drug | Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight) |
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| COMPLETED |
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| NOT COMPLETED |
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| Delayed-enhanced MRI With Dotarem |
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| CCTA With Xenetix 350 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Included Patients | All patients included in the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Prevalence of Occult Myocardial Scar on Delayed-enhanced MRI in Asymptomatic Patients With Type 2 Diabetes Mellitus | Posted | Count of Participants | Participants | From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations) |
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| 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:
| Posted | Count of Participants | Participants | From 1 week to 2 months (after the collection of data corresponding to cardiac MRI and CCTA examinations) |
|
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From the signature of the informed consent form until 30 minutes after the end of CCTA examination i.e. from 2 days to 3 months
The analysis of adverse events was performed on the safety population that includes all patients receiving at least one injection of contrast agent regardless of the quantity. Post-injection AEs collected between Dotarem and Xenetix 350 injection, during Xenetix 350 injection and after Xenetix 350 injection are presented.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Between Dotarem and Xenetix 350 Injection | Adverse events that occurred after Dotarem injection (MRI examination) and before Xenetix 350 injection (CCTA examination) | 0 | 328 | 0 | 328 | 8 | 328 |
| EG001 | During Xenetix 350 Injection | Adverse events that occurred during injection of Xenetix 350 (CCTA examination) | 0 | 328 | 0 | 328 | 12 | 328 |
| EG002 | After Xenetix 350 Injection | Adverse events that occurred after the injection of Xenetix 350 (CCTA examination) | 0 | 328 | 0 | 328 | 7 | 328 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA | Systematic Assessment |
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| Burning sensation | Nervous system disorders | MedDRA | Systematic Assessment |
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| Head discomfort | Nervous system disorders | MedDRA | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Dubourdieu, Head of Clinical Projects and Medical Writing | Guerbet | +33(0)1 45 91 50 00 | corinne.dubourdieu@guerbet.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C093233 | iobitridol |
| C072417 | gadoterate meglumine |
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