NCT02361073

Brief Summary

The event-related potentials may be different in patients with Takotsubo cardiomyopathy than in patients without Takotsubo.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 11, 2015

Status Verified

February 1, 2015

Enrollment Period

4.2 years

First QC Date

January 9, 2013

Last Update Submit

February 10, 2015

Conditions

Takotsubo Cardiomyopathy

Keywords

Stress-induced cardiomyopathyERP

Outcome Measures

Primary Outcomes (1)

  • Event-related potentials

    up to 1 year

Study Arms (3)

Takotsubo

Healthy

ACS

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Takotsubo Cardiomyopathy compared with healthy subjects and patients with ACS.

You may qualify if:

  • Age \>18 years
  • Written informed consent
  • Takotsubo cardiomyopathy for group 1. ACS for group 3.

You may not qualify if:

  • Psychiatric diseases
  • Impaired versus, non compliant patients, heart disease for group 2.
  • Takotsubo-like syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Magdeburg

Magdeburg, 39112, Germany

RECRUITING

MeSH Terms

Conditions

Takotsubo Cardiomyopathy

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesVentricular Dysfunction, LeftVentricular Dysfunction

Central Study Contacts

Samir M Said, MD

CONTACT

+49-3916715206samir.said@med.ovgu.de

Katja Mueller

CONTACT

+49-1604429214katja.mueller@med.ovgu.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2013

First Posted

February 11, 2015

Study Start

June 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 11, 2015

Record last verified: 2015-02

Locations

DE(1)