Hemodynamics During the Soccer Championship 2012 | NCT01617863

Studies
Hemodynamics During the Soccer Championship 2012

NCT01617863

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Jul 3, 2012Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Severe Cardiomyopathy
Angina, Unstable
Myocardial Infarction
Angina, Stable

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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jun 8, 2012

First Submission Date that Met QC Criteria

Jun 9, 2012

First Posted Date

Jun 12, 2012Estimated

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

Jul 2, 2012

Last Update Posted Date

Jul 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD. Dr. med Michael Reppel, PD Dr. med Reppel, University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Name	Class
Universitätsklinikum Greifswald, Greifswald, Mecklenburg-Vorpommern, Germany	UNKNOWN
Universitätsklinikum Erlangen, Erlangen, Bayern, Germany	UNKNOWN
Universitätsklinikum Hamburg-Eppendorf	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to determine in soccer fans whether and to which extend positive or negative emotions during the European soccer Championship affects Central Hemodynamics, Arterial Stiffness, Heartrate and Endothelial Dysfunktion.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

180Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Best fit:

cardiomyopathy "severe myocardial disease leading to heart failure"
Angina, stable for at least 7 days
Myocardial infarction during 4 weeks before inclusion, actually stable condition
Angina, Stable, CCS II-IV

Exclusion Criteria:

not interested in soccer championship
age <18y
dementia
atrial tachycardia
drug/alcohol abuse
chronic kidney disease, stage 5
pulmonary/tricuspid valve insufficiency/stenoses
non compliant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

primary care clinic, clinical employees, students

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael Reppel, PD. Dr. med	UKSH- Lübeck Medizinische Klinik 2	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Erlangen		Erlangen	Bavaria	91054	Germany
Universitätsklinikum Eppendorf

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies
D000789	Angina, Unstable
D009203	Myocardial Infarction
D060050	Angina, Stable

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000787	Angina Pectoris
D017202	Myocardial Ischemia

Browse Leaves

Not provided

Browse Branches

Not provided