The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- serum level of high sensitive troponin at several timepoints
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •age: 18-45 year
- •willing to sign informed consent
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
Outcomes
Primary Outcomes
serum level of high sensitive troponin at several timepoints
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported