Coronary DiseaseL-RIPC-CABGNCT04779008
Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After CABG
A study testing remote ischemic preconditioning (RIPC) in people with Coronary Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
Trial summary
Remote Ischemic preconditioning (RIPC) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.Two large randomized controlled trials demonstrated a perioperative cardioprotective effect of RIPC (reduced troponin levels), but… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- remote ischemic preconditioning (RIPC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2021to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Three coronary artery lesions, CABG surgery was planned
Who cannot join
- The patients could not tolerate ripc;
- peripheral vascular disease affecting upper limbs
- Acute myocardial infarction complicated with cardiogenic shock,in recent 30 days,
- Emergency cases
- Severe structural heart disease and severe arrhythmia ;
- The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively;
Show all 11Show fewer
- Severe liver, renal and pulmonary disease
- Mental disorder can't cooperate;
- Inability to give informed consent;
- Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
- pregnant;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fuwai central China cardiovascular Hospital
Zhengzhou, Henan
Quan Guo, MD, xinyiguoquan@163.com
Muwei Life, MD
About this study
Official title: Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After Coronary Artery Bypass Grafting
Remote Ischemic preconditioning (RIPC) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.Two large randomized controlled trials demonstrated a perioperative cardioprotective effect of RIPC (reduced troponin levels), but did not find that a single preoperative RIPC improved long-term outcomes of coronary artery bypass grafting(CABG).The effect of a single RIPC before CABG may be too short. This study aims to investigate whether long-term RIPC improved myocardial perfusion in patients 3 months and 6 months after CABG surgery , and to detect changes in blood vascular endothelial growth factor, Nitrc Oxide, adenosine,and Endothelin-1, and to observe MACCE event rates at 12 months.
Read the detailed description
A total of 210 patients were randomly divided into three groups according to the inclusion and exclusion criteria, with 70 patients in each group.
Experimental Group 1:
The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) 1 hours before surgery, then normal surgery, and RIPC was performed on the second day after surgery and every day after surgery, which lasted for 1 year.
Experiment Group 2:
Patients underwent once RIPC 1 hours before surgery, and then normal medical procedures were performed with no additional intervention.
Control group:
Patients did not receive any additional intervention. All patients were evaluated in three ways. First: 7days and 3 months after surgery , the quantitative examination of myocardial blood flow was conducted to observe the improvement of myocardial blood perfusion.
Second: The changes in the concentrations of vascular colorectal growth factor, Nitrc Oxide, adenosine, and endothelin-1.
Third, patients were evaluated for 6 months and 12months MACCE incidence (cardiovascular death, Nonfatal myocardial infarction, unplanned revascularization, and stroke).
- Conditions
- Coronary Disease
- Being tested
- remote ischemic preconditioning (RIPC)
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remote ischemic preconditioning (RIPC)Other
Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1 | Experimental | Routine treatment + interventions:The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) before surgery, then normal surgery, and RIPC was performed on the second day and Once RIPC/day after CABG for one year. Receives: Other: remote ischemic preconditioning (RIPC) |
| Experimental Group 2 | Experimental | Routine treatment + interventions:Patients underwent a RIPC before surgery, and then normal medical procedures were performed with no additional intervention. Receives: Other: remote ischemic preconditioning (RIPC) |
| Control group | No intervention | routine treatment, no RIPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of MBF by SPECT
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)
Measured: 3 months
Change of MPR by SPECT
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
Measured: 3 months
Change of MBF by CE
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
Measured: 3 months
Change of MPR by CE
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial perfusion reserve(MPR)
Measured: 3 months
Secondary outcomes (15)
MBF by SPECT
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)
Measured: 1 weeks
MPR by SPECT
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
Measured: 1 weeks
MBF by CE
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
Measured: 1 weeks
MPR by CE
Myocardial perfusion was evaluated by contrast echocardiography(CE): and myocardial perfusion reserve(MPR)
Measured: 1 weeks
Rate of major adverse cardiovascular and cerebrovascular events
Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke
Measured: 12 months
Rate of major adverse cardiovascular and cerebrovascular events
Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke
Measured: 6 months
Concentration of VEGF
Blood vascular colorectal growth factor
Measured: -1days,1 weeks,3months post surgery
Concentration of NO
Blood Nitrc Oxide
Measured: -1days,1 weeks,3months post surgery
Concentration of BK
Blood bradykinin
Measured: -1days,1 weeks,3months post surgery
Concentration of ET-1
Blood endothelin-1
Measured: -1days,1 weeks,3months post surgery
Concentration of adenosine
Blood adenosine
Measured: -1days,1 weeks,3months post surgery
Concentration of troponin
Blood troponin
Measured: Before surgery and after surgery
6 minute Walk Test
6 minute Walk Test
Measured: 1 weeks, 3/6/9 and 12 months post surgery
Seattle angina questionnaire score
Including the limited degree of physical activity, stable state of angina pectoris, angina attack frequency, treatment satisfaction, disease recognition and recognition of 5 dimensions.
Measured: 1 weeks, 3/6/9 and 12 months post surgery
Change of LVEF by SPECT
left ventricular ejection fraction was evaluated by Single Photon Emission Computed Tomography(SPECT):
Measured: 1 weeks, 3 months,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start10 Mar 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary 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
- Parallel groups
- Model description
- Experimental Group 1:The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) 4 hours before surgery, then normal surgery, and RIPC was performed on the second day after surgery and every day after surgery, which lasted for 1 year. Experiment Group 2: Patients underwent once RIPC 4 hours before surgery, and then normal medical procedures were performed with no additional intervention. Control group: Patients did not receive any additional intervention.
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Institute of Cardiovascular Epidemiology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muwei Li, Ph.D, Principal investigator, Fuwai central China cardiovascular hospotialZhaoyun Cheng, Ph.D, Principal investigator, Fuwai central China cardiovascular hospotial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779008
- Sponsor's protocol ID
- HenanICE202101
- Acronym
- L-RIPC-CABG
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2021
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: One year after the end of the trial, other outside investigators could access the original data on reasonable requests
Publications
Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
PubMed 18456674Lau JK, Roy P, Javadzadegan A, Moshfegh A, Fearon WF, Ng M, Lowe H, Brieger D, Kritharides L, Yong AS. Remote Ischemic Preconditioning Acutely Improves Coronary Microcirculatory Function. J Am Heart Assoc. 2018 Oct 2;7(19):e009058. doi: 10.1161/JAHA.118.009058.
PubMed 30371329Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Boning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schon J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Hasenclever D, Zacharowski K; RIPHeart Study Collaborators. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.
PubMed 26436208Hausenloy DJ, Candilio L, Evans R, Ariti C, Jenkins DP, Kolvekar S, Knight R, Kunst G, Laing C, Nicholas J, Pepper J, Robertson S, Xenou M, Clayton T, Yellon DM; ERICCA Trial Investigators. Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery. N Engl J Med. 2015 Oct 8;373(15):1408-17. doi: 10.1056/NEJMoa1413534. Epub 2015 Oct 5.
PubMed 26436207
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT04779008
- Acronym / sponsor ID
- L-RIPC-CABG / HenanICE202101
- Conditions
- Coronary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Henan Institute of Cardiovascular EpidemiologyUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Mar 2021 (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 preconditioning (RIPC) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.Two large randomized controlled trials demonstrated a perioperative cardioprotective effect of RIPC (reduced troponin levels), but did not find that a single preoperative RIPC improved long-term outcomes of coronary artery bypass grafting(CABG).The effect of a single RIPC before CABG may be too short. This study aims to investigate whether long-term RIPC improved myocardial perfusion in patients 3 months and 6 months after CABG surgery , and to detect changes in blood vascular endothelial growth factor, Nitrc Oxide, adenosine,and Endothelin-1, and to observe MACCE event rates at 12 months.
Detailed description
A total of 210 patients were randomly divided into three groups according to the inclusion and exclusion criteria, with 70 patients in each group.
Experimental Group 1:
The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) 1 hours before surgery, then normal surgery, and RIPC was performed on the second day after surgery and every day after surgery, which lasted for 1 year.
Experiment Group 2:
Patients underwent once RIPC 1 hours before surgery, and then normal medical procedures were performed with no additional intervention.
Control group:
Patients did not receive any additional intervention. All patients were evaluated in three ways. First: 7days and 3 months after surgery , the quantitative examination of myocardial blood flow was conducted to observe the improvement of myocardial blood perfusion.
Second: The changes in the concentrations of vascular colorectal growth factor, Nitrc Oxide, adenosine, and endothelin-1.
Third, patients were evaluated for 6 months and 12months MACCE incidence (cardiovascular death, Nonfatal myocardial infarction, unplanned revascularization, and stroke).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Experimental Group 1:The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) 4 hours before surgery, then normal surgery, and RIPC was performed on the second day after surgery and every day after surgery, which lasted for 1 year. Experiment Group 2: Patients underwent once RIPC 4 hours before surgery, and then normal medical procedures were performed with no additional intervention. Control group: Patients did not receive any additional intervention.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: remote ischemic preconditioning (RIPC)Routine treatment + interventions:The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) before surgery, then normal surgery, and RIPC was performed on the second day and Once RIPC/day after CABG for one year. |
| Experimental Group 2 | Experimental | Other: remote ischemic preconditioning (RIPC)Routine treatment + interventions:Patients underwent a RIPC before surgery, and then normal medical procedures were performed with no additional intervention. |
| Control group | No intervention | –routine treatment, no RIPC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Three coronary artery lesions, CABG surgery was planned
Key exclusion criteria (11 listed)
- The patients could not tolerate ripc;
- peripheral vascular disease affecting upper limbs
- Acute myocardial infarction complicated with cardiogenic shock,in recent 30 days,
- Emergency cases
- Severe structural heart disease and severe arrhythmia ;
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)Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff inflated to 200 mmHg. | Other | Experimental Group 1, Experimental Group 2 |
Primary outcome
Change of MBF by SPECT
Time frame: 3 months
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)
Change of MPR by SPECT
Time frame: 3 months
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
Change of MBF by CE
Time frame: 3 months
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
Change of MPR by CE
Time frame: 3 months
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial perfusion reserve(MPR)
15 secondary outcomes
MBF by SPECT
Time frame: 1 weeks
MPR by SPECT
Time frame: 1 weeks
MBF by CE
Time frame: 1 weeks
MPR by CE
Time frame: 1 weeks
Rate of major adverse cardiovascular and cerebrovascular events
Time frame: 12 months
Rate of major adverse cardiovascular and cerebrovascular events
Time frame: 6 months
Concentration of VEGF
Time frame: -1days,1 weeks,3months post surgery
Concentration of NO
Time frame: -1days,1 weeks,3months post surgery
Concentration of BK
Time frame: -1days,1 weeks,3months post surgery
Concentration of ET-1
Time frame: -1days,1 weeks,3months post surgery
Concentration of adenosine
Time frame: -1days,1 weeks,3months post surgery
Concentration of troponin
Time frame: Before surgery and after surgery
6 minute Walk Test
Time frame: 1 weeks, 3/6/9 and 12 months post surgery
Seattle angina questionnaire score
Time frame: 1 weeks, 3/6/9 and 12 months post surgery
Change of LVEF by SPECT
Time frame: 1 weeks, 3 months,6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 18456674Hausenloy DJ, Yellon DM. Remote ischaemic preconditioning: underlying mechanisms and clinical application. Cardiovasc Res. 2008 Aug 1;79(3):377-86. doi: 10.1093/cvr/cvn114. Epub 2008 May 2.
- Background: PubMed 30371329Lau JK, Roy P, Javadzadegan A, Moshfegh A, Fearon WF, Ng M, Lowe H, Brieger D, Kritharides L, Yong AS. Remote Ischemic Preconditioning Acutely Improves Coronary Microcirculatory Function. J Am Heart Assoc. 2018 Oct 2;7(19):e009058. doi: 10.1161/JAHA.118.009058.
- Background: PubMed 26436208Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Boning A, Niemann B, Roesner J, Kletzin F, Strouhal U, Reyher C, Laufenberg-Feldmann R, Ferner M, Brandes IF, Bauer M, Stehr SN, Kortgen A, Wittmann M, Baumgarten G, Meyer-Treschan T, Kienbaum P, Heringlake M, Schon J, Sander M, Treskatsch S, Smul T, Wolwender E, Schilling T, Fuernau G, Hasenclever D, Zacharowski K; RIPHeart Study Collaborators. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery. N Engl J Med. 2015 Oct 8;373(15):1397-407. doi: 10.1056/NEJMoa1413579. Epub 2015 Oct 5.
- Background: PubMed 26436207Hausenloy DJ, Candilio L, Evans R, Ariti C, Jenkins DP, Kolvekar S, Knight R, Kunst G, Laing C, Nicholas J, Pepper J, Robertson S, Xenou M, Clayton T, Yellon DM; ERICCA Trial Investigators. Remote Ischemic Preconditioning and Outcomes of Cardiac Surgery. N Engl J Med. 2015 Oct 8;373(15):1408-17. doi: 10.1056/NEJMoa1413534. Epub 2015 Oct 5.
- Individual participant dataSharing planned: No. One year after the end of the trial, other outside investigators could access the original data on reasonable requests
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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.
Muwei Li, Ph.D principal investigator
Fuwai central China cardiovascular hospotial
Zhaoyun Cheng, Ph.D principal investigator
Fuwai central China cardiovascular hospotial
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 Coronary Disease, run by Henan Institute of Cardiovascular Epidemiology at 1 site in China.
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 11 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: looking for participants now, as of the sponsor's last update on 18 Sep 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Quan Guo, MD (+8615670510031, xinyiguoquan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of MBF by SPECT (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779008, which also lists 4 linked publications.
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 18 Sep 2025; AzTrials last refreshed its copy on 1 Nov 2026.