Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System (Pro-MagIC)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04166903 |
|
Recruitment Status : Unknown
Verified March 2020 by Johannes Scherr, Balgrist University Hospital.
Recruitment status was: Recruiting
First Posted : November 18, 2019
Last Update Posted : March 13, 2020
|
| Tracking Information | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | November 13, 2019 | |||||||||
| First Posted Date | November 18, 2019 | |||||||||
| Last Update Posted Date | March 13, 2020 | |||||||||
| Actual Study Start Date | November 15, 2019 | |||||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
Changes of right ventricular systolic function (RV-EF) [ Time Frame: 10 years ] Echocardiography
|
|||||||||
| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
|
|||||||||
| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Prospective Follow-up, Marathon, Long Term, Inflammation and Cardiovascular System | |||||||||
| Official Title | Prospective Long Term Follow-up Analysis of Exercise-induced Physiological Changes in Male Runners | |||||||||
| Brief Summary | Pro-MagIC is a prospective observational study and includes participants of the Be-MaGIC-Study 2009 (n=277/NCT00933218). We aim to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years. | |||||||||
| Detailed Description | Physical activity is associated with health benefits. Acute prolonged and strenuous exercise, i.e. Marathon running, leads to hemodynamic, endothelial and myocardial functional changes. Whether these myocardial, endothelial and hemodynamic changes can also develop and persist through repetitive extreme and prolonged physical activity is currently still a matter of controversy. In addition, it is not known whether adaptations and changes over time can develop into clinically relevant cardiovascular events with negative health consequences in healthy athletes. The aim of this study is to detect exercise-induced physiological changes (inter alia of the cardiovascular system) induced by repetitive ultra-endurance strain over a period of 10 years. For this purpose, 277 male participants from the Be-MaGIC study (Marathon 2009) are examined in this prospective observational study. A single examination with the following components will take place: Anthropometry, clinical examination, laboratory, resting / exercise electrocardiography cardiopulmonary stress test, echocardiography, and fundus camera. Further examinations will be conducted in participants with abnormal examination results in line with current clinical recommendations. |
|||||||||
| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
|||||||||
| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples Without DNA Description: blood sample: whole blood, serum, plasma
|
|||||||||
| Sampling Method | Non-Probability Sample | |||||||||
| Study Population | Participants of the Be-MaGIC-Study (2009) | |||||||||
| Condition | Participants of the Be-MaGIC-Study 2009 | |||||||||
| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | Schoenfeld J, Schindler MJ, Haller B, Holdenrieder S, Nieman DC, Halle M, La Gerche A, Scherr J. Prospective long-term follow-up analysis of the cardiovascular system in marathon runners: study design of the Pro-MagIC study. BMJ Open Sport Exerc Med. 2020 Jul 19;6(1):e000786. doi: 10.1136/bmjsem-2020-000786. eCollection 2020. | |||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||||||||
| Recruitment Information | ||||||||||
| Recruitment Status | Unknown status | |||||||||
| Estimated Enrollment |
277 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | December 2020 | |||||||||
| Estimated Primary Completion Date | March 2020 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria: Declaration of consent Participants must have participated in the Be-MaGIC study in 2009
Exclusion Criteria: - |
|||||||||
| Sex/Gender |
|
|||||||||
| Ages | 30 Years to 70 Years (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Germany | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT04166903 | |||||||||
| Other Study ID Numbers | ProMagIC-Study | |||||||||
| Has Data Monitoring Committee | No | |||||||||
| U.S. FDA-regulated Product |
|
|||||||||
| IPD Sharing Statement |
|
|||||||||
| Current Responsible Party | Johannes Scherr, Balgrist University Hospital | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Technical University of Munich | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators |
|
|||||||||
| Investigators |
|
|||||||||
| PRS Account | Technical University of Munich | |||||||||
| Verification Date | March 2020 | |||||||||