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CompletedNCT01660828Updated Aug 9, 2012

Exercise Test and Cardiac Injury

An interventional study of remote ischemic preconditioning (RIPC) in Cardiovascular Disease, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-08-09.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiovascular Disease

Keywords

  • Exercise induced (high sensitive) troponin release
  • Ischemia reperfusion injury
  • Remote ischemic preconditioning
03

In context

Cardiovascular Diseases

5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 984 studies on the registry; 135 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Intensive cycling test preceded by RIPC

    Intensive cycling test preceded by a RIPC protocol.

    Other: remote ischemic preconditioning (RIPC)

  • No intervention
    No intervention/ RIPC

    Intensive cycling test not preceded by a RIPC protocol.

Interventions

  • Otherremote ischemic preconditioning (RIPC)

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

06

What researchers measure

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

    Time frame: timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise

07

Study locations

1 site
  • Radboud University Nijmegen Medical Centre
    Nijmegen, 6500 HB, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01660828
Responsible party
Sponsor
First posted
Aug 9, 2012
Start date
Sep 2011
Primary completion
Dec 2011
Completion
Jan 2012
Last update
Aug 9, 2012

Study contacts

G. Rongen, MD, PhD
principal investigator · Radboud University Nijmegen Medial Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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