Exercise Test and Cardiac Injury

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.

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remote ischemic preconditioning (RIPC)

Other

RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia

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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2012
First posted: Aug 9, 2012
Registry last updated: Aug 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed