Myocardial Injury is Not Related to Training Levels Among... | NCT00560040

Studies
Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon

NCT00560040

Sponsor

Stanford University

Status

Completed

Last Update Posted

Nov 19, 2007Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

Troponin
Natriuretic Peptide, Brain
Exercise
Echocardiography

Interventions

Not provided

Countries

Not provided

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

May 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

Jan 2006

Primary Completion Date

Not provided

Completion Date

Oct 2006Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 19, 2007Estimated

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

Nov 16, 2007

Last Update Posted Date

Nov 19, 2007Estimated

Name	Class
Abbott Point of Care	INDUSTRY

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

To determine if pre-race training effects heart damage induced by marathon running.

Detailed Description

Investigations have shown increases in cardiac markers consistent with myocardial injury and left ventricular dysfunction in both recreational and elite athletes after endurance exercise. Pre-race training is an important component of endurance events, yet its effect on cardiovascular injury is unclear. The present study aimed to evaluate the correlation between myocardial injury and training level in recreational marathon runners utilizing both objective and subjective measures.

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

53Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any healthy male or female aged 18-65 planning to run the 2006 Silicon Valley Marathon.

Exclusion Criteria:

Hypertension
Hyperlipidemia
Diabetes
History of myocardial infarction or acute coronary syndrome

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suzanne M Miller, MD	Stanford Hospital and Clinics	Principal Investigator

Locations

Not provided