Status:
COMPLETED
Sympathetic Heart Innervation in Patients With Tako-Tsubo Cardiomyopathy
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Apical Ballooning Syndrome
Nervous System Diseases, Sympathetic
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
Stress (tako-tsubo) cardiomyopathy (SC) is a rapidly reversible form of acute heart failure reported to be triggered by stressful events and associated with a distinctive left ventricular (LV) contrac...
Detailed Description
Study design Each patient will be assessed with history and physical examination, 12-lead ECG, serum troponin, coronary arteriography, and LV angiogram (an average of 6 hours after admission to the ho...
Eligibility Criteria
Inclusion
- acute onset of a cardiovascular event, usually associated with substernal chest pain, initially regarded as ST-segment elevation myocardial infarction/evolving coronary syndrome;
- systolic dysfunction, predominantly characterized by akinesia/hypokinesia of the mid-to-distal portion of the LV chamber, with hypercontractile basal LV;
Exclusion
- presence, by angiography, of significant atherosclerotic luminal narrowing in each of the 3 epicardial coronary arteries (0 to \< 25%) (- presence of pheochromocytoma, myocarditis, or hypertrophic cardiomyopathy.
- coexisting conditions that limited life expectancy to less than 12 months or that could affect a patient's compliance with the protocol
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01524861
Start Date
December 1 2011
End Date
January 1 2016
Last Update
January 27 2016
Active Locations (1)
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1
Dept Geriatric and Metabolic diseases SUN
Naples, Italy