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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01885975
Other study ID # 13-003419
Secondary ID
Status Completed
Phase N/A
First received June 20, 2013
Last updated February 13, 2015
Start date July 2013
Est. completion date September 2014

Study information

Verified date February 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

1. Patients who have suffered with ABS

2. Adults (18 years or older)

3. Able to read English at a 6th grade level (questionnaires are self-administered and written in English)

Exclusion criteria:

1. Have withdrawn from the registry

2. Have died

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Range of personality traits as assessed by the "NEO-PI-3" The "NEO PI-3" measures the five major domains of personality, which are:
Neuroticism
Extraversion
Openness
Agreeableness
Conscientiousness
Baseline: the traits will be assessed once upon enrollment into the study No
See also
  Status Clinical Trial Phase
Completed NCT00975559 - The Relationship Between the Response to Mental Stress and Vascular Endothelial Function N/A
Completed NCT00586183 - Cardiac Sympathetic Activity in Patients With the Apical Ballooning Syndrome N/A
Completed NCT01524861 - Sympathetic Heart Innervation in Patients With Tako-Tsubo Cardiomyopathy Phase 4