Age Gender Left Ventricular Mass and Cardiac Troponin T | NCT01100710

Studies
Age Gender Left Ventricular Mass and Cardiac Troponin T

NCT01100710

Sponsor

Heidelberg University

Status

Completed

Last Update Posted

Apr 9, 2010Estimated

Enrollment

116Actual

Phase

Not provided

Conditions

Heart Failure

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 2007

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

Mar 2007

Primary Completion Date

Mar 2007Actual

Completion Date

Dec 2009Actual

First Submitted Date

Apr 8, 2010

First Submission Date that Met QC Criteria

Apr 8, 2010

First Posted Date

Apr 9, 2010Estimated

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

Apr 8, 2010

Last Update Posted Date

Apr 9, 2010Estimated

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 the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals.

Detailed Description

We sought to investigate the relative contribution of functional or anatomic parameters as assessed by cardiac magnetic resonance tomography (cMRI, 1.5 Tesla), and clinical variables including increasing age and gender on high sensitivity cTnT (TnThs) levels in healthy individuals. Therefore we measured TnThs in serum samples of 120 healthy volunteers aged between 20 and 70 years. All individuals underwent cMRI including stress testing using dobutamine or adenosine.TnThs concentrations were related to cMRI and clinical findings. Partial correlation, as well as linear and hierarchical regression analyses were used to identify independent predictors and their relative contribution for prediction of TnThs values.

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

No data available

No data is available for this block.

Enrollment

116Actual

Label	Type	Description	Intervention Names
healthy volunteers

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

agreement, age > 18 years, men and women

Exclusion Criteria:

measurable heart disease, any chronic or acute disease, intake of meds, hypertension, Diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

residents of Heidelberg and urban hinterland

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Evangelos Giannitsis, Prof.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Heidelberg		Heidelberg	Baden-Würtemberg	69120	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18230357	Background	Apple FS, Smith SW, Pearce LA, Ler R, Murakami MM, Benoit MO, Levy C, Dumas C, Paul JL. Use of the bioMerieux VIDAS troponin I ultra assay for the diagnosis of myocardial infarction and detection of adverse events in patients presenting with symptoms suggestive of acute coronary syndrome. Clin Chim Acta. 2008 Apr;390(1-2):72-5. doi: 10.1016/j.cca.2007.12.016. Epub 2008 Jan 11.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases