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

Coronary Disease Clinical Trial

— L-RIPC-CABG  

Official title:

Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779008
• Other study ID #: HenanICE202101
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: August 10, 2023

Study information

• Verified date: February 2023
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: Quan Guo, MD
• Phone: +8615670510031
• Email: xinyiguoquan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: August 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Three coronary artery lesions, CABG surgery was planned

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Coronary Disease

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.

Locations

Country	Name	City	State
China	Fuwai central China cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of MBF by SPECT	Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)	3 months
Primary	Change of MPR by SPECT	Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)	3 months
Primary	Change of MBF by CE	Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)	3 months
Primary	Change of MPR by CE	Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial perfusion reserve(MPR)	3 months
Secondary	MBF by SPECT	Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial blood flow(MBF)	1 weeks
Secondary	MPR by SPECT	Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)	1 weeks
Secondary	MBF by CE	Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)	1 weeks
Secondary	MPR by CE	Myocardial perfusion was evaluated by contrast echocardiography(CE): and myocardial perfusion reserve(MPR)	1 weeks
Secondary	Rate of major adverse cardiovascular and cerebrovascular events	Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke	12 months
Secondary	Rate of major adverse cardiovascular and cerebrovascular events	Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke	6 months
Secondary	Concentration of VEGF	Blood vascular colorectal growth factor	-1days,1 weeks,3months post surgery
Secondary	Concentration of NO	Blood Nitrc Oxide	-1days,1 weeks,3months post surgery
Secondary	Concentration of BK	Blood bradykinin	-1days,1 weeks,3months post surgery
Secondary	Concentration of ET-1	Blood endothelin-1	-1days,1 weeks,3months post surgery
Secondary	Concentration of adenosine	Blood adenosine	-1days,1 weeks,3months post surgery
Secondary	Concentration of troponin	Blood troponin	Before surgery and after surgery
Secondary	6 minute Walk Test	6 minute Walk Test	1 weeks, 3/6/9 and 12 months post surgery
Secondary	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
Secondary	Change of LVEF by SPECT	left ventricular ejection fraction was evaluated by Single Photon Emission Computed Tomography(SPECT):	1 weeks, 3 months,6 months