Cardiovascular DiseaseNCT01660828
Exercise Test and Cardiac Injury
A study testing remote ischemic preconditioning (RIPC) in people with Cardiovascular Disease, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- remote ischemic preconditioning (RIPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age: 18-45 year
- willing to sign informed consent
- healthy
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
Official title: The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers
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
- Being tested
- remote ischemic preconditioning (RIPC)
- Keywords
- Exercise induced (high sensitive) troponin release, Ischemia reperfusion injury, Remote ischemic preconditioning
- Medical subject headings
- Cardiovascular Diseases, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioning (RIPC)Other
RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia
| Study group | Role | What they receive |
|---|---|---|
| Intensive cycling test preceded by RIPC | Active comparator | Intensive cycling test preceded by a RIPC protocol. Receives: Other: remote ischemic preconditioning (RIPC) |
| No intervention/ RIPC | No intervention | Intensive cycling test not preceded by a RIPC protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: timepoints t= baseline, 0, 1, 2, 3,4 and 8 hours after finishing exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G. Rongen, MD, PhD, Principal investigator, Radboud University Nijmegen Medial Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660828
- Sponsor's protocol ID
- EXTROP2
- Status last verified
- Aug 2011
- First submitted
- 23 Jul 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Remote Ischemic Preconditioning on Plasma Troponin I Appearance After a Standardized Cycling Test in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01660828
- Acronym / sponsor ID
- EXTROP2
- Conditions
- Cardiovascular Disease
- Keywords
- Exercise induced (high sensitive) troponin release, Ischemia reperfusion injury, Remote ischemic preconditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive cycling test preceded by RIPC | Active comparator | Other: remote ischemic preconditioning (RIPC)Intensive cycling test preceded by a RIPC protocol. |
| No intervention/ RIPC | No intervention | –Intensive cycling test not preceded by a RIPC protocol. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age: 18-45 year
- willing to sign informed consent
- healthy
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remote ischemic preconditioning (RIPC)RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia | Other | Intensive cycling test preceded by RIPC |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G. Rongen, MD, PhD principal investigator
Radboud University Nijmegen Medial Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remote ischemic preconditioning (RIPC) in people with Cardiovascular Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012.