Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome
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Purpose
Our hypothesis is that altered cardiac sympathetic activity is present and may contribute to the myocardial stunning observed in the apical ballooning syndrome.
Aim: Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction using carbon-11 hydroxyephedrine (C-11 HED), a positron emission tomography (PET) tracer, in patients with the apical ballooning syndrome.
| Condition | Intervention |
|---|---|
|
Apical Ballooning Syndrome |
Procedure: PET scan |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome |
- Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction [ Time Frame: During PET scan ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | March 2006 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction.
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Procedure: PET scan
The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction.
Other Name: Positron emission scan
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Detailed Description:
General methods: Five patients will undergo PET scans within a few days of or during the initial hospital admission for apical ballooning syndrome and during follow-up at 4 to 6 weeks to evaluate regional perfusion using N-13 ammonia and cardiac sympathetic activity with C-11 HED.
PET scanning protocol On the morning of the study, patients will arrive at the Mayo Clinic PET Imaging Center in a fasting state. The use of medications will be ascertained and recorded. An intravenous cannula will be placed in each arm. The subject will then be positioned in the PET scanner . After optimal positioning of the left ventricle within the field of view, a transmission scan will be performed with either a germanium-68 or CT source for subsequent attenuation correction. The PET scanning sequence is outlined below. Because 11C-HED uptake is dependent on flow characteristics, a flow study will be performed using N-13 ammonia. N-13 ammonia (10 to 20 mCi) will be injected over 20 seconds, and dynamic acquisition will be performed for 20 minutes with the following sequence:16 frames at 3 seconds, 10 frames at 12 seconds, and 2 frames at 240 seconds. Following a 50-minute period of N-13 ammonia decay, 11C-HED (20mCi) will be injected over 30 seconds, and a dynamic acquisition will be performed with the following sequence: 6 frames at 30 seconds, 2 frames at 60 seconds, 2 frames at 150 seconds, 2 frames at 300 seconds, 2 frames at 600 seconds, and 1 frames at 1,200 seconds. To correct for 11C-metabolites in the blood activity, venous samples will be drawn at 0, 1, 5, 10, 20, 40, and 60 minutes (total ~25 ml of blood) after the injection of C-11 HED. Heart rate, systemic blood pressure, and a 12-lead electrocardiogram will be obtained noninvasively with each peak isotope activity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Transient akinesis or dyskinesis of the left ventricular apical and mid-ventricular segments with regional wall-motion abnormalities extending beyond a single epicardial vascular distribution.
- Absence of obstructive coronary disease or angiographic evidence of acute plaque rupture.
- New electrocardiographic abnormalities (either ST-segment elevation or T-wave inversion.
- Absence of recent significant head trauma, intracranial bleeding, pheochromocytoma, myocarditis, hypertrophic cardiomyopathy.
Exclusion Criteria:
- Hemodynamically unstable patients (requiring pressor support) will be excluded.
- Breastfeeding women.
- Pregnant women (urine pregnancy test required within 48 hours prior to each set of PET scans.
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Abhiram Prasad, Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT00586183 History of Changes |
| Other Study ID Numbers: | 06-002093 |
| Study First Received: | December 21, 2007 |
| Last Updated: | December 21, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mayo Clinic:
|
Ventricular Remodeling |
Additional relevant MeSH terms:
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Takotsubo Cardiomyopathy Ventricular Dysfunction, Left Ventricular Dysfunction Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013