Investigation of Cardiac Function and Cardiovascular Risk... | NCT00500773

Status Module

Record Verification Date

Apr 2014

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

Jul 2007

Primary Completion Date

Mar 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Jul 11, 2007

First Submission Date that Met QC Criteria

Jul 11, 2007

First Posted Date

Jul 13, 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

Apr 30, 2014

Last Update Posted Date

May 1, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Name	Class
Ludwig-Maximilians - University of Munich	OTHER

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 purpose of this study is to determine the cardiovascular risk involved in the exertional exercise of marathon running. The researchers aim to investigate the beneficial effects of regular well-dosed exercise on health and compare these findings with the effects of the extreme strains of marathon running. Subclinical injuries to heart and arteries are being investigated in different groups of runners, including obese participants.

Detailed Description

Regular exercise leads to an improvement of cardiovascular risc factors in patients with coronary heart disease, atherosclerosis and metabolic disorders. Aerobic exercise has anti-inflammatory effects. In contrast, the exertional exercise of marathon running causes an acute pro-inflammatory impulse. This may lead to myocardial injury and, in case of preexisting plaques, may result in plaque rupture and acute myocardial infarction.

The researchers aim to define the critical role of inflammatory markers and cardiovascular risk factors as a predictor of an increased risk for myocardial and endothelial dysfunction in marathon runners.

The study groups are divided into average trained runners (40 km/week), average trained obese runners and highly trained runners (> 70km/week). Training programmes are supervised by professional coaches. Individual scientific marathon contests are organized for the assessments.

Diagnostic tools include measurements of pulse wave velocity and heart rate turbulence, echocardiography and, for the first time, MRI-scans pre- and post marathon running. Additionally, cardiovascular markers such as endothelial progenitor cells (EPCs)and adiponectin are measured. Inflammatory markers include c-reactive protein (CRP), interleukins and tumor necrosis factor.

Conditions Module

Conditions

Modes of Exercise and Myocardial and Endothelial Function
Microcirculation
Subclinical Endorgan Damage
Obesity

Keywords

cardiovascular risc factors
inflammation
aerobic and exertional exercise

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

60Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men aged 30-60 years
Obese subjects: BMI > 27 and waist circumference > 102cm

Exclusion Criteria:

manifested heart disease
insulin dependent diabetes mellitus
multiple drug therapy
GFR < 60 ml/min.
claustrophobia
metal implants

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Healthy male marathon runners with no more than one treated cardiovascular risk factor aged 30-60 years. Participation of at least a 1/2 marathon in recent history.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henner Hanssen, MD	Department of Prevention and Sportmedicine, Technical University Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Prevention and Sportsmedicine, Technical University of Munich		Connollystrasse 32, Munich	Bavaria	80809	Germany

References Module

Citations

Not provided

ID	Term
D009765	Obesity
D007249	Inflammation

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes