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Investigator departing institution and enrollment not met.
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| Name | Class |
|---|---|
| Biosense Webster, Inc. | INDUSTRY |
| Washington University School of Medicine | OTHER |
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Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm - PET/CT Imaging With [C-11] MHED | Experimental | Single Arm - positron emission tomography/computed tomography imaging with [C-11] meta-Hydroxyephedrine tracer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [C-11] Meta-hydroxyephedrine radioactive tracer (MHED) | Drug | this tracer detects the distribution of sympathetic nerve fibers in the left ventricle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between PET Data and Electroanatomic Data | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm - PET/CT Imaging With [C-11] MHED | Patients receiving positron emission/computed tomography imaging with [C-11]-meta-hydroxyephedrine (mHED) tracer |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm - PET/CT Imaging With [C-11] MHED | Patients receiving PET/CT imaging with [C-11] MHED tracer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Correlation Between PET Data and Electroanatomic Data | No outcomes were measured as no patients had complete data. | Posted | 1 week |
|
|
12 months
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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 | Single Arm - PET/CT Imaging With [C-11] MHED | Patients receiving PET/CT imaging with [C-11] MHED tracer |
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Overall study data is limited given the study was terminated before reaching the enrollment goal.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Bryant, MPH | Mercy Research | 314-251-8827 | michelle.bryant@mercy.net |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2023 | Nov 12, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D045002 | 3-alpha-Hydroxysteroid Dehydrogenase (B-Specific) |
| ID | Term |
|---|---|
| D015096 | 3-Hydroxysteroid Dehydrogenases |
| D006913 | Hydroxysteroid Dehydrogenases |
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D064430 | NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases |