The Role of Emotional Stress in Patients With Stress-indu... | NCT02361073

Studies
The Role of Emotional Stress in Patients With Stress-induced Cardiomyopathy

NCT02361073

Sponsor

University of Magdeburg

Status

Unknown status

Last Update Posted

Feb 11, 2015Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Takotsubo Cardiomyopathy

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Aug 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Jan 9, 2013

First Submission Date that Met QC Criteria

Feb 10, 2015

First Posted Date

Feb 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2015

Last Update Posted Date

Feb 11, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

In patients with Takotsubo diagnosed by coronary angiography, the event-related potentials are investigated and compared with a control group, which consists of subjects without Takotsubo.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Measure	Description	Time Frame
Event-related potentials		up to 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Samir M Said, MD	Contact	+49-3916715206		samir.said@med.ovgu.de
Katja Mueller	Contact	+49-1604429214		katja.mueller@med.ovgu.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Magdeburg	Recruiting	Magdeburg		39112	Germany

Condition Browse Module

MeSH Terms

ID	Term
D054549	Takotsubo Cardiomyopathy

Ancestor Terms

ID	Term
D009202	Cardiomyopathies
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D018487	Ventricular Dysfunction, Left

Browse Leaves

Not provided

Browse Branches

Not provided