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Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT00586183
Collaborator
(none)
1
Enrollment
1
Location
1
Arm
9
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: PET scan
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Official Title:
Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome
Study Start Date :
Mar 1, 2006
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Arms and Interventions

Arm Intervention/Treatment
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.

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 Names:
  • Positron emission scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction [During PET scan]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Abhiram Prasad, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00586183
    Other Study ID Numbers:
    • 06-002093
    First Posted:
    Jan 4, 2008
    Last Update Posted:
    Jan 4, 2008
    Last Verified:
    Mar 1, 2006
    Keywords provided by , ,
    Ventricular Remodeling
    Additional relevant MeSH terms:
    Takotsubo Cardiomyopathy
    Syndrome

    Study Results

    No Results Posted as of Jan 4, 2008