Cardiac Biomarkers After Marathon Running and Coronary At... | NCT03738631

Studies
Cardiac Biomarkers After Marathon Running and Coronary Atherosclerosis

NCT03738631

Sponsor

University of Turku

Status

Completed

Last Update Posted

May 8, 2024Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Finland

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 2024

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

Aug 17, 2018Actual

Primary Completion Date

Dec 1, 2022Actual

Completion Date

Dec 1, 2022Actual

First Submitted Date

Sep 21, 2018

First Submission Date that Met QC Criteria

Nov 9, 2018

First Posted Date

Nov 13, 2018Actual

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

May 7, 2024

Last Update Posted Date

May 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study evaluates cardiac biomarkers and their association to coronary artery disease in marathon runners.

Detailed Description

The MaraCat study is an observational prospective study evaluating the association between cardiac biomarkers and coronary artery disease in 43 runners participating in the 2018 Paavo Nurmi Marathon. The study participants were recruited according to two age criteria - under 35 years and over 44 years of age. Comprehensive laboratory samples were collected immediately after the run, while the control workup was done in a separate visit with no significant physical excercise in the preceding two weeks. In the under 35 years -group, the control workup included an echocardiography, ecg and blood samples. In the over 44 years group, the control studies included coronary CT, echocardiography, ecg and laboratory tests.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

43Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac Troponin-T level after marathon	Cardiac troponin-T levels (ng/L), [electrochemiluminescence (ECLIA) method]	0-30minutes after finishing the Paavo Nurmi Marathon
Association Cardiac troponin-T level and coronary CT findings	Cardiac troponin-T levels (ng/L), [electrochemiluminescence (ECLIA) method]	Cardiac Troponin-T 0-30 minutes after finishing the Paavo Nurmi Marathon. Control Troponin-T levels and coronary CT angiography at control visit (>30days after marathon).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age under 35 years or over 44 years
Participant of Paavo Nurmi Marathon 2018
Informed consent signed

Exclusion Criteria:

No informed consent
existing coronary artery disease

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Male participants of the Paavo Nurmi Marathon 2018

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Turku University Hospital, Heart Center		Turku			Finland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Under 35 years
Over 44 years