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Exercise Test and Cardiac Injury

NCT ID: NCT01660828

Last Updated: 2012-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cardiovascular Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive cycling test preceded by RIPC

Intensive cycling test preceded by a RIPC protocol.

Group Type ACTIVE_COMPARATOR

remote ischemic preconditioning (RIPC)

Intervention Type OTHER

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

No intervention/ RIPC

Intensive cycling test not preceded by a RIPC protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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remote ischemic preconditioning (RIPC)

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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G. Rongen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Nijmegen Medial Centre

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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EXTROP2

Identifier Type: -

Identifier Source: org_study_id