NCT00586183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
Last Updated

January 4, 2008

Status Verified

March 1, 2006

Enrollment Period

9 months

First QC Date

December 21, 2007

Last Update Submit

December 21, 2007

Conditions

Keywords

Ventricular Remodeling

Outcome Measures

Primary Outcomes (1)

  • Assess the extent and reversibility of cardiac adrenergic neuronal dysfunction

    During PET scan

Study Arms (1)

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

Interventions

PET scanPROCEDURE

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.

Also known as: Positron emission scan
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Takotsubo CardiomyopathyVentricular Remodeling

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular DysfunctionPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Abhiram Prasad, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

March 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

January 4, 2008

Record last verified: 2006-03

Locations