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Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

This study has been completed.

Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00586183
  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

MedlinePlus related topics:   Nuclear Scans   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Open Label, Single Group Assignment
Official Title:   Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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
1: Experimental
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.
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.

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00586183

Locations
United States, Minnesota
Mayo Clinic    
      Rochester, Minnesota, United States, 55905

Sponsors and Collaborators
Mayo Clinic

Investigators
Principal Investigator:     Abhiram Prasad, MD     Mayo Clinic    
  More Information


Mayo Clinic Clinical Trials  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Mayo Clinic ( Abhiram Prasad )
Study ID Numbers:   06-002093
First Received:   December 21, 2007
Last Updated:   December 21, 2007
ClinicalTrials.gov Identifier:   NCT00586183
Health Authority:   United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Ventricular Remodeling  

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on October 03, 2008




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