NCT01885975

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

February 16, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

June 20, 2013

Last Update Submit

February 13, 2015

Conditions

Apical Ballooning Syndrome

Keywords

Apical Ballooning syndromePersonality

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted among participants in the Mayo Clinic Apical Ballooning Registry. These patients were prospectively diagnosed with Apical Ballooning Syndrome at the time of presentation with their acute illness, and consented to participation in a registry. They are residents of Olmsted County, and the surrounding regions for which the Mayo Clinic serves as a tertiary care center. Enrollment in the registry requires satisfaction of standard criteria for the diagnosis of ABS and includes the administration of a standardized questionnaire. Subjects have agreed to participate in yearly follow up questionnaires about their health status.

You may qualify if:

  • Patients who have suffered with ABS
  • Adults (18 years or older)
  • Able to read English at a 6th grade level (questionnaires are self-administered and written in English)

You may not qualify if:

  • Have withdrawn from the registry
  • Have died

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular Dysfunction

Study Officials

  • Abhiram Prasad, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 20, 2013

First Posted

June 25, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

February 16, 2015

Record last verified: 2015-02

Locations

US(1)