Exercise Test and Cardiac Injury

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Other: remote ischemic preconditioning (RIPC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18-45 year willing to sign informed consent healthy 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intensive cycling test preceded by RIPC<br>Intensive cycling test preceded by a RIPC protocol. | Other: remote ischemic preconditioning (RIPC)<br>* RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia<br>|
| No Intervention: No intervention/ RIPC<br>Intensive cycling test not preceded by a RIPC protocol. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise induced (high sensitive) troponin release, Ischemia reperfusion injury, Remote ischemic preconditioning