Exercise Test and Cardiac Injury

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660828
• Other study ID #: EXTROP2
• Status: Completed
• Phase: N/A
• First received: July 23, 2012
• Last updated: August 8, 2012
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: August 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Other:
• remote ischemic preconditioning (RIPC)
RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No