Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After CABG

NCT04779008 | Recruiting

• 1 other identifier: HenanICE202101
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Coronary Disease

Outcome Measures

Primary Outcomes (4)

• Change of MBF by SPECT

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

  3 months

• Change of MPR by SPECT

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

  3 months

• Change of MBF by CE

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

  3 months

• Change of MPR by CE

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

  3 months

Secondary Outcomes (15)

• MBF by SPECT

  1 weeks

• MPR by SPECT

  1 weeks

• MBF by CE

  1 weeks

• MPR by CE

  1 weeks

• Rate of major adverse cardiovascular and cerebrovascular events

  12 months

Study Arms (3)

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.

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.

Other: remote ischemic preconditioning （RIPC）

Control group

NO INTERVENTION

routine treatment, no RIPC

Interventions

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.

Experimental Group 1; Experimental Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Three coronary artery lesions, CABG surgery was planned

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai central China cardiovascular Hospital

Zhengzhou, Henan, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 18456674 BACKGROUND

• 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.

  PMID: 30371329 BACKGROUND

• 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.

  PMID: 26436208 BACKGROUND

• 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.

  PMID: 26436207 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Muwei Li, Ph.D

  Fuwai central China cardiovascular hospotial

  PRINCIPAL INVESTIGATOR

• Zhaoyun Cheng, Ph.D

  Fuwai central China cardiovascular hospotial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quan Guo, MD

CONTACT

+8615670510031; xinyiguoquan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: March 3, 2021
• Study Start: March 10, 2021
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)