Myocardial InfarctionPhase 4NCT03169426
Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning
A Phase 4 study testing Beta Blockers Carvedilol Phosphate in people with Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Beta Blockers Carvedilol Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2017to 10 Nov 2017
- Phase
- Phase 4
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteer
- Not taking any medication
Who cannot join
- BMI < 18 kg/m2 or > 30 kg/m2
- Allergic history of any medication
- Baseline SBP > 150 mmHg or < 100 mmHg
- Baseline DBP > 100 mmHg or < 50 mmHg
- Strenuous exercise, excessive caffeine or alcohol, smoking 24 h prior to experiment
- Cannot undergoing remote ischemic conditioning for any reason
- Refuse to enroll
Trial locations and contacts
1 site in 1 country.
About this study
Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has not been well documented. The purpose of the study is to investigate the effect of beta-blocker on remote ischemic conditioning in healthy volunteers.
Read the detailed description
This study is prospective cross-over study investigating effect of beta-blocker on cardioprotective role of remote ischemic conditioning. Eleven male healthy volunteers are going to take oral beta-blocker (carvedilol, 12.5 mg once) or not before undergoing remote ischemic conditioning (consisting of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion of upper arm), separated by 6-day wash-out period. To evaluate cardioprotective effect of remote ischemic conditioning, blood samples will be obtained before and after remote ischemic conditioning. Form the samples, human dialysate will be obtained and be perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Changes of infarct size of the rat heart will be compared between the beta-blocker and control groups.
- Conditions
- Myocardial Infarction
- Being tested
- Beta Blockers Carvedilol Phosphate
- Keywords
- remote ischemic conditioning, beta-blocker
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta Blockers Carvedilol PhosphateDrug
Subjects are going to take Beta Blockers Carvedilol Phosphate (12.5mg once) before undergoing remote ischemic conditioning.
| Study group | Role | What they receive |
|---|---|---|
| Beta Blockers Carvedilol Phosphate | Experimental | Subjects are going to take beta-blocker (carvedilol, 12.5 mg once) before undergoing remote ischemic conditioning.
Intervention: taking beta-blocker Receives: Drug: Beta Blockers Carvedilol Phosphate |
| Control | No intervention | Subjects are going to undergo remote ischemic conditioning without taking any drug. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers
Infarct size measurement after perfusing the rat heart with human serum-derived dialysate and comparison before and after remote ischemic conditioning performed to healthy volunteers
Measured: 24 hour after remote ischemic conditioning to healthy volunteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start17 May 2017
- Primary completion10 Nov 2017
- Study completion10 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169426
- Sponsor's protocol ID
- BB_RIPC
- Status last verified
- Feb 2018
- First submitted
- 16 May 2017
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Beta-blocker on Cardioprotective Effect of Remote Ischemic Conditioning
- ClinicalTrials.gov ID
- NCT03169426
- Acronym / sponsor ID
- BB_RIPC
- Conditions
- Myocardial Infarction
- Keywords
- remote ischemic conditioning, beta-blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Nov 2017 (actual)
- First posted
- 30 May 2017 (actual)
- 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.
Remote ischemic conditioning has been shown to protect myocardium from ischemia-reperfusion injury during cardiac intervention or cardiac surgery. However, effect of beta-blocker, commonly used cardiovascular medication in patients with cardiac diseases such as hypertension or angina pectoris, on cardioprotective role of remote ischemic conditioning has not been well documented. The purpose of the study is to investigate the effect of beta-blocker on remote ischemic conditioning in healthy volunteers.
Detailed description
This study is prospective cross-over study investigating effect of beta-blocker on cardioprotective role of remote ischemic conditioning. Eleven male healthy volunteers are going to take oral beta-blocker (carvedilol, 12.5 mg once) or not before undergoing remote ischemic conditioning (consisting of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion of upper arm), separated by 6-day wash-out period. To evaluate cardioprotective effect of remote ischemic conditioning, blood samples will be obtained before and after remote ischemic conditioning. Form the samples, human dialysate will be obtained and be perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Changes of infarct size of the rat heart will be compared between the beta-blocker and control groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta Blockers Carvedilol Phosphate | Experimental | Drug: Beta Blockers Carvedilol PhosphateSubjects are going to take beta-blocker (carvedilol, 12.5 mg once) before undergoing remote ischemic conditioning. Intervention: taking beta-blocker |
| Control | No intervention | –Subjects are going to undergo remote ischemic conditioning without taking any drug. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male volunteer
- Not taking any medication
Key exclusion criteria (7 listed)
- BMI < 18 kg/m2 or > 30 kg/m2
- Allergic history of any medication
- Baseline SBP > 150 mmHg or < 100 mmHg
- Baseline DBP > 100 mmHg or < 50 mmHg
- Strenuous exercise, excessive caffeine or alcohol, smoking 24 h prior to experiment
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 |
|---|---|---|
| Beta Blockers Carvedilol PhosphateSubjects are going to take Beta Blockers Carvedilol Phosphate (12.5mg once) before undergoing remote ischemic conditioning. | Drug | Beta Blockers Carvedilol Phosphate |
Primary outcome
Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers
Time frame: 24 hour after remote ischemic conditioning to healthy volunteers
Infarct size measurement after perfusing the rat heart with human serum-derived dialysate and comparison before and after remote ischemic conditioning performed to healthy volunteers
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 20 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Yunseok Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Beta Blockers Carvedilol Phosphate in people with Myocardial Infarction, run by Seoul National University Hospital at 1 site in South Korea.
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 2 inclusion and 7 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 20 Feb 2018. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in infarct size of rat heart perfused with human dialysate after taking beta-blocker or not to evaluate the effect of beta blocker on remote ischemic conditioning performed to healthy volunteers (time frame: 24 hour after remote ischemic conditioning to healthy volunteers). 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 20 Feb 2018.