Trial record 4 of 13 for:    "Stress cardiomyopathy"

Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586183
First received: December 21, 2007
Last updated: NA
Last verified: March 2006
History: No changes posted
  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

Resource links provided by NLM:


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
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 Name: Positron emission scan

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

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:
Takotsubo Cardiomyopathy
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014