L-RIPC-CABG: Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After CABG
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group 1 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）
Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
|
| Experimental: Experimental Group 2 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）
Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
|
| No Intervention: Control group routine treatment, no RIPC |
Outcome Measures
Primary Outcome Measures
- Change of MBF by SPECT [3 months]
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)
- Change of MPR by SPECT [3 months]
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
- Change of MBF by CE [3 months]
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
- Change of MPR by CE [3 months]
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial perfusion reserve(MPR)
Secondary Outcome Measures
- MBF by SPECT [1 weeks]
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)
- MPR by SPECT [1 weeks]
Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
- MBF by CE [1 weeks]
Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
- MPR by CE [1 weeks]
Myocardial perfusion was evaluated by contrast echocardiography(CE): and myocardial perfusion reserve(MPR)
- Rate of major adverse cardiovascular and cerebrovascular events [12 months]
Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke
- Rate of major adverse cardiovascular and cerebrovascular events [6 months]
Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke
- Concentration of VEGF [-1days，1 weeks，3months post surgery]
Blood vascular colorectal growth factor
- Concentration of NO [-1days，1 weeks，3months post surgery]
Blood Nitrc Oxide
- Concentration of BK [-1days，1 weeks，3months post surgery]
Blood bradykinin
- Concentration of ET-1 [-1days，1 weeks，3months post surgery]
Blood endothelin-1
- Concentration of adenosine [-1days，1 weeks，3months post surgery]
Blood adenosine
- Concentration of troponin [Before surgery and after surgery]
Blood troponin
- 6 minute Walk Test [1 weeks, 3/6/9 and 12 months post surgery]
6 minute Walk Test
- Seattle angina questionnaire score [1 weeks, 3/6/9 and 12 months post surgery]
Including the limited degree of physical activity, stable state of angina pectoris, angina attack frequency, treatment satisfaction, disease recognition and recognition of 5 dimensions.
- Change of LVEF by SPECT [1 weeks, 3 months,6 months]
left ventricular ejection fraction was evaluated by Single Photon Emission Computed Tomography(SPECT):
Eligibility Criteria
Criteria
Inclusion Criteria:
- Three coronary artery lesions, CABG surgery was planned
Exclusion Criteria:
-
The patients could not tolerate ripc;
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peripheral vascular disease affecting upper limbs
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Acute myocardial infarction complicated with cardiogenic shock，in recent 30 days,
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Emergency cases
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Severe structural heart disease and severe arrhythmia ；
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The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively;
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Severe liver, renal and pulmonary disease
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Mental disorder can't cooperate;
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Inability to give informed consent；
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Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
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pregnant;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fuwai central China cardiovascular Hospital | Zhengzhou | Henan | China |
Sponsors and Collaborators
- Henan Institute of Cardiovascular Epidemiology
Investigators
- Principal Investigator: Muwei Li, Ph.D, Fuwai central China cardiovascular hospotial
- Principal Investigator: Zhaoyun Cheng, Ph.D, Fuwai central China cardiovascular hospotial
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Review.
- 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.
- Meybohm P, Bein B, Brosteanu O, Cremer J, Gruenewald M, Stoppe C, Coburn M, Schaelte G, Böning 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, Schön 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.
- HenanICE202101