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Exercise Test and Cardiac Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01660828
First Posted: August 9, 2012
Last Update Posted: August 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Radboud University
  Purpose
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.

Condition Intervention
Cardiovascular Disease Other: remote ischemic preconditioning (RIPC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: September 2011
Study Completion Date: January 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intensive cycling test preceded by RIPC
Intensive cycling test preceded by a RIPC protocol.
Other: remote ischemic preconditioning (RIPC)
RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia
No Intervention: No intervention/ RIPC
Intensive cycling test not preceded by a RIPC protocol.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01660828


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: G. Rongen, MD, PhD Radboud University Nijmegen Medial Centre
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01660828     History of Changes
Other Study ID Numbers: EXTROP2
First Submitted: July 23, 2012
First Posted: August 9, 2012
Last Update Posted: August 9, 2012
Last Verified: August 2011

Keywords provided by Radboud University:
Exercise induced (high sensitive) troponin release
Ischemia reperfusion injury
Remote ischemic preconditioning

Additional relevant MeSH terms:
Cardiovascular Diseases