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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Fuwai central China cardiovascular Hospital

    Zhengzhou, Henan

    Quan Guo, MD, xinyiguoquan@163.com

    Muwei Life, MD

    Recruiting

Other trials in China

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).

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 groups in NCT04779008
Study groupRoleWhat they receive
Experimental Group 1ExperimentalRoutine 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 2ExperimentalRoutine 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 groupNo interventionroutine treatment, no RIPC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of MBF by SPECT

    Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)

    Measured: 3 months

  2. Change of MPR by SPECT

    Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)

    Measured: 3 months

  3. Change of MBF by CE

    Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)

    Measured: 3 months

  4. Change of MPR by CE

    Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial perfusion reserve(MPR)

    Measured: 3 months

Secondary outcomes (15)
  1. MBF by SPECT

    Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)

    Measured: 1 weeks

  2. MPR by SPECT

    Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)

    Measured: 1 weeks

  3. MBF by CE

    Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)

    Measured: 1 weeks

  4. MPR by CE

    Myocardial perfusion was evaluated by contrast echocardiography(CE): and myocardial perfusion reserve(MPR)

    Measured: 1 weeks

  5. Rate of major adverse cardiovascular and cerebrovascular events

    Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke

    Measured: 12 months

  6. Rate of major adverse cardiovascular and cerebrovascular events

    Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke

    Measured: 6 months

  7. Concentration of VEGF

    Blood vascular colorectal growth factor

    Measured: -1days,1 weeks,3months post surgery

  8. Concentration of NO

    Blood Nitrc Oxide

    Measured: -1days,1 weeks,3months post surgery

  9. Concentration of BK

    Blood bradykinin

    Measured: -1days,1 weeks,3months post surgery

  10. Concentration of ET-1

    Blood endothelin-1

    Measured: -1days,1 weeks,3months post surgery

  11. Concentration of adenosine

    Blood adenosine

    Measured: -1days,1 weeks,3months post surgery

  12. Concentration of troponin

    Blood troponin

    Measured: Before surgery and after surgery

  13. 6 minute Walk Test

    6 minute Walk Test

    Measured: 1 weeks, 3/6/9 and 12 months post surgery

  14. 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

  15. 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.

  1. First posted3 Mar 2021
  2. Study start10 Mar 2021
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

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)
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 18456674
  • Lau 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 30371329
  • Meybohm 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 26436208
  • Hausenloy 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

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.

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