Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

Apical Ballooning Syndrome Clinical Trial

Official title:

Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586183
• Other study ID #: 06-002093
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: December 21, 2007
• Start date: March 2006
• Est. completion date: December 2006

Study information

• Verified date: March 2006
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Apical Ballooning Syndrome
• Syndrome
• Takotsubo Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction		During PET scan	No

External Links

•   Mayo Clinic Clinical Trials