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Exercise Test and Cardiac Injury

R

Radboud University Medical Center

Status

Completed

Conditions

Cardiovascular Disease

Treatments

Other: remote ischemic preconditioning (RIPC)

Study type

Interventional

Funder types

Other

Identifiers

NCT01660828
EXTROP2

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Intensive cycling test preceded by RIPC
Active Comparator group
Description:
Intensive cycling test preceded by a RIPC protocol.
Treatment:
Other: remote ischemic preconditioning (RIPC)
No intervention/ RIPC
No Intervention group
Description:
Intensive cycling test not preceded by a RIPC protocol.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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