Exercise Test and Cardiac Injury

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Other: remote ischemic preconditioning (RIPC)

• Registration Number: NCT01660828
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin levels. The underlying mechanism is not yet elucidated, but could be explained by changes due to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion injury. If the mechanism underlying the troponin release during exercise is similar to that of ischemia reperfusion injury (IRI), than it should be susceptible to remote ischemic preconditioning (RIPC) as RIPC is a well validated technique to reduce IRI. To test this hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding RIPC.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Study First Submitted: 2012-07-23
• Study First Submitted QC: 2012-08-08
• Last Update Submitted: 2012-08-08
• Study First Posted: 2012-08-09
• Last Update Posted: 2012-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• age: 18-45 year
• willing to sign informed consent
• healthy

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Exclusion Criteria

• hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure > 90 mmHg)
• any cardiovascular abnormality in past medical history, physical examination or ECG, including QTc interval
• drug abuse
• alcohol abuse (> 3 units/day)
• smoking during the last 2 years
• BMI >30 kg/m2
• inability to perform bicycle test
• the presence of an absolute or relative contra-indication for exercise (table 2 in protocol)
• the presence of diabetes (fasting glucose > 6.9 mmol/L, non-fasting glucose >11.0 mmol/L; if non-fasting glucose is > 6.9 mmol/L, blood glucose measurement will be repeated in fasting condition and should then not exceed 6.9 mmol/L)
• total cholesterol in blood 6.6 mmol/L or higher

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intensive cycling test preceded by RIPC	remote ischemic preconditioning (RIPC)	Intensive cycling test preceded by a RIPC protocol.

Primary Outcome Measures

Name	Time	Method
serum level of high sensitive troponin at several timepoints	timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise	serum level of high sensitive troponin in response to intensive exercise test with or without RIPC at several timepoints

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Netherlands