Exercise Test and Cardiac Injury

NCT01660828 | Completed

• 1 other identifier: EXTROP2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease

Keywords

Exercise induced (high sensitive) troponin release; Ischemia reperfusion injury; Remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intensive cycling test preceded by RIPC

ACTIVE COMPARATOR

Intensive cycling test preceded by a RIPC protocol.

Other: remote ischemic preconditioning (RIPC)

No intervention/ RIPC

NO INTERVENTION

Intensive cycling test not preceded by a RIPC protocol.

Interventions

remote ischemic preconditioning (RIPC) OTHER

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

Intensive cycling test preceded by RIPC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 18-45 year
• willing to sign informed consent
• healthy

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Reperfusion Injury

Condition Hierarchy (Ancestors)

Vascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• G. Rongen, MD, PhD

  Radboud University Nijmegen Medial Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: August 9, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2012
• Last Updated: August 9, 2012

Record last verified: 2011-08

Locations

NL (1)