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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Experimental Group 2 | Experimental | Routine treatment + interventions:Patients underwent a RIPC before surgery, and then normal medical procedures were performed with no additional intervention. |
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| Control group | No Intervention | routine treatment, no RIPC |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| MBF by SPECT | Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF) | 1 weeks |
| MPR by SPECT | Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Guo, MD | Contact | +8615670510031 | xinyiguoquan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Muwei Li, Ph.D | Fuwai central China cardiovascular hospotial | Principal Investigator |
| Zhaoyun Cheng, Ph.D | Fuwai central China cardiovascular hospotial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai central China cardiovascular Hospital | Recruiting | Zhengzhou | Henan | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18456674 | Background | 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. | |
| 30371329 | 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. |
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One year after the end of the trial, other outside investigators could access the original data on reasonable requests
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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.
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| 1 weeks |
| MBF by CE | Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF) | 1 weeks |
| MPR by CE | Myocardial perfusion was evaluated by contrast echocardiography(CE): and myocardial perfusion reserve(MPR) | 1 weeks |
| Rate of major adverse cardiovascular and cerebrovascular events | Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke | 12 months |
| Rate of major adverse cardiovascular and cerebrovascular events | Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke | 6 months |
| Concentration of VEGF | Blood vascular colorectal growth factor | -1days，1 weeks，3months post surgery |
| Concentration of NO | Blood Nitrc Oxide | -1days，1 weeks，3months post surgery |
| Concentration of BK | Blood bradykinin | -1days，1 weeks，3months post surgery |
| Concentration of ET-1 | Blood endothelin-1 | -1days，1 weeks，3months post surgery |
| Concentration of adenosine | Blood adenosine | -1days，1 weeks，3months post surgery |
| Concentration of troponin | Blood troponin | Before surgery and after surgery |
| 6 minute Walk Test | 6 minute Walk Test | 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. | 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): | 1 weeks, 3 months,6 months |
| 26436208 | 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. |
| 26436207 | 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. |