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Lack of Subject Recruitment
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The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with 99mTc-maraciclatide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tc99m-Maraciclatide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tc99m-Maraciclatide | Drug | Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of Active Myocardial Angiogenesis/Remodeling | Due to the lack of subject enrollment, efficacy data were not analyzed. | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction | Due to the lack of subject enrollment, efficacy data were not analyzed. | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arnold Jacobson, MD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tc99m-Maraciclatide Injection | The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Tc99m-Maraciclatide Injection | The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evidence of Active Myocardial Angiogenesis/Remodeling | Due to the lack of subject enrollment, efficacy data were not analyzed. | Due to the lack of subject enrollment, efficacy data were not analyzed. | Posted | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. |
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| Secondary | Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction | Due to the lack of subject enrollment, efficacy data were not analyzed. | Due to the lack of subject enrollment, efficacy data were not analyzed. | Posted | Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. |
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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 | Tc99m-Maraciclatide Injection | The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures). | 0 | 4 | 2 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 15.0 | Non-systematic Assessment |
| |
| Diabetes Mellitus-Inadequate Control | Metabolism and nutrition disorders | MedDRA 15.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arnold Jacobson, M.D. | GE Healthcare | 1-609-514-6325 | Arnold.Jacobson@ge.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C521545 | NC100692 |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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