Patients With Elective Aortic Valve ReplacementPhase 4NCT01946087
Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
A Phase 4 study testing Remote ischemic preconditioning at left upper arm in people with Patients With Elective Aortic Valve Replacement, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Patients With Elective Aortic Valve Replacement
- What is being tested?
- Remote ischemic preconditioning at left upper arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Apr 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR
Who cannot join
- diabetes mellitus,
- coronary stenosis ≥70%,
- renal failure (serum creatinine > 2.0 mg/dL),
- upper arm peripheral vascular disease,
- LV ejection fraction <50%
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium
- Being tested
- Remote ischemic preconditioning at left upper arm, Control group
- Keywords
- Remote ischemic preconditioning, cardiac surgery, left ventricular hypertrophy, reperfusion injury salvage kinase
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioning at left upper armProcedure or surgery
Placement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) \& 5 min reperfusion (deflation)
Control groupProcedure or surgery
keeping the cuff deflated
| Study group | Role | What they receive |
|---|---|---|
| RIPC group | Experimental | Not described Receives: Procedure: Remote ischemic preconditioning at left upper arm |
| Control group | Placebo comparator | Not described Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of CK-MB and Tn-T
Measured: baseline
Serum levels of CK-MB and Tn-T
Measured: 12-hour after surgery
Serum levels of CK-MB and Tn-T
Measured: 24-hour after surgery
Secondary outcomes (2)
Myocardial activation of protective signaling pathway
Measured: Before commencement of CPB
Myocardial activation of protective signaling pathway
Measured: After taking off CPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Elective Aortic Valve ReplacementStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946087
- Sponsor's protocol ID
- 4-2012-0283
- Status last verified
- Nov 2016
- First submitted
- 4 Sep 2013
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning Induces Myocardial RISK Signaling Pathway in Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT01946087
- Acronym / sponsor ID
- 4-2012-0283
- Keywords
- Remote ischemic preconditioning, cardiac surgery, left ventricular hypertrophy, reperfusion injury salvage kinase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 19 Sep 2013 (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.
The aim of this study is to investigate whether RIPC protects the heart against ischemia reperfusion injury on the concentrically hypertrophied myocardium
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC group | Experimental | Procedure: Remote ischemic preconditioning at left upper arm |
| Control group | Placebo comparator | Procedure: Control group |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥20 years with severe degenerative AS presenting concentric remodeling of the LV, who were scheduled for AVR
Key exclusion criteria (5 listed)
- diabetes mellitus,
- coronary stenosis ≥70%,
- renal failure (serum creatinine > 2.0 mg/dL),
- upper arm peripheral vascular disease,
- LV ejection fraction <50%
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 at left upper armPlacement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) \& 5 min reperfusion (deflation) | Procedure or surgery | RIPC group |
| Control groupkeeping the cuff deflated | Procedure or surgery | Control group |
Primary outcome
Serum levels of CK-MB and Tn-T
Time frame: baseline
Serum levels of CK-MB and Tn-T
Time frame: 12-hour after surgery
Serum levels of CK-MB and Tn-T
Time frame: 24-hour after surgery
2 secondary outcomes
Myocardial activation of protective signaling pathway
Time frame: Before commencement of CPB
Myocardial activation of protective signaling pathway
Time frame: After taking off CPB
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 22 Nov 2016.
Related trials for Patients With Elective Aortic Valve Replacement
Recruiting
Staged Complete Revascularization for Coronary Artery Disease vs Medical Management Alone in Patients With AS Undergoing Transcatheter Aortic Valve Replacement
Aortic Stenosis, Coronary Artery Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Remote ischemic preconditioning at left upper arm in people with Patients With Elective Aortic Valve Replacement, run by Yonsei University 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 1 inclusion and 5 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 22 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Serum levels of CK-MB and Tn-T (time frame: baseline). The study lists 3 primary outcomes in all. 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 22 Nov 2016.