Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After CABG
- Conditions
- Coronary Disease
- Interventions
- Other: remote ischemic preconditioning （RIPC）
- Registration Number
- NCT04779008
- Lead Sponsor
- Henan Institute of Cardiovascular Epidemiology
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
- Three coronary artery lesions, CABG surgery was planned
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group 1 remote ischemic preconditioning （RIPC） 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. Experimental Group 2 remote ischemic preconditioning （RIPC） Routine treatment + interventions:Patients underwent a RIPC before surgery, and then normal medical procedures were performed with no additional intervention.
- Primary Outcome Measures
Name Time Method 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 MBF by SPECT 3 months Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): 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
Name Time Method Concentration of ET-1 -1days，1 weeks，3months post surgery Blood endothelin-1
MBF by SPECT 1 weeks Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): 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 6 months Cardiovascular death, non-fatal acute myocardial infarction, revascularization, stroke
Change of LVEF by SPECT 1 weeks, 3 months,6 months left ventricular ejection fraction was evaluated by Single Photon Emission Computed Tomography(SPECT):
Concentration of NO -1days，1 weeks，3months post surgery Blood Nitrc Oxide
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.
MBF by CE 1 weeks Myocardial perfusion was evaluated by contrast echocardiography(CE): myocardial blood flow(MBF)
Concentration of BK -1days，1 weeks，3months post surgery Blood bradykinin
Concentration of adenosine -1days，1 weeks，3months post surgery Blood adenosine
6 minute Walk Test 1 weeks, 3/6/9 and 12 months post surgery 6 minute Walk Test
MPR by SPECT 1 weeks Myocardial perfusion was evaluated by Single Photon Emission Computed Tomography(SPECT): myocardial perfusion reserve(MPR)
Concentration of VEGF -1days，1 weeks，3months post surgery Blood vascular colorectal growth factor
Concentration of troponin Before surgery and after surgery Blood troponin
Trial Locations
- Locations (1)
Fuwai central China cardiovascular Hospital
🇨🇳Zhengzhou, Henan, China