Long-term Remote Ischemic Preconditioning Improve the Prognosis of Myocardial Infarction Patients With Emergency Reperfusion Therapy

Myocardial Infarction, Acute Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03018873
• Other study ID #: XuanwuH-RIPC1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 21, 2016
• Last updated: January 10, 2017
• Start date: December 2016

Study information

• Verified date: July 2016
• Source: Xuanwu Hospital, Beijing
• Contact: Liu zhi, doctor
• Phone: 13911517967
• Email: xwyy168[@]sina.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

Patients with acute myocardial infarction (AMI) are in critical condition. When primary percutaneous coronary intervention (PCI) was performing, no-reflow, reperfusion injury，heart failure, heart rupture, malignant arrhythmia maybe happen. It was reported remote ischemic preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will investigate whether once RIPC before primary PCI or long-term RIPC can improve AMI patients short-term and long-term (1 year) prognosis. 400 STEMI patients undergoing primary PCI were randomly divided into 3 groups: long-term RIPC group (once preoperative RIPC and once RIPC/day after PCI), preoperative RIPC group (once preoperative RIPC), control group (without RIPC). Cardiac troponin (TNI), high-sensitivity C-reactive protein (hsCRP), adenosine, vascular endothelial growth factor (VEGF), hypoxia inducible factor-1 (HIF-1), echocardiography and magnetic resonance （MR）were detected 1 day, 1 month and 1 year after PCI. Patients will be followed up by telephone at the end of one year. The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 18-80 years;

• ST segment elevation myocardial infarction (STEMI);

• Plan to primary percutaneous coronary intervention.

Exclusion Criteria:

• Age more than 80;

• renal failure with creatinine >2 mg/dl;

• reject taking part in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Other:
• remote ischemic preconditioning (RIPC)
once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing

References & Publications (12)

Bøtker HE, Kharbanda R, Schmidt MR, Bøttcher M, Kaltoft AK, Terkelsen CJ, Munk K, Andersen NH, Hansen TM, Trautner S, Lassen JF, Christiansen EH, Krusell LR, Kristensen SD, Thuesen L, Nielsen SS, Rehling M, Sørensen HT, Redington AN, Nielsen TT. Remote ischaemic conditioning before hospital admission, as a complement to angioplasty, and effect on myocardial salvage in patients with acute myocardial infarction: a randomised trial. Lancet. 2010 Feb 27;375(9716):727-34. doi: 10.1016/S0140-6736(09)62001-8. — View Citation

Crimi G, Pica S, Raineri C, Bramucci E, De Ferrari GM, Klersy C, Ferlini M, Marinoni B, Repetto A, Romeo M, Rosti V, Massa M, Raisaro A, Leonardi S, Rubartelli P, Oltrona Visconti L, Ferrario M. Remote ischemic post-conditioning of the lower limb during primary percutaneous coronary intervention safely reduces enzymatic infarct size in anterior myocardial infarction: a randomized controlled trial. JACC Cardiovasc Interv. 2013 Oct;6(10):1055-63. doi: 10.1016/j.jcin.2013.05.011. — View Citation

D'Ascenzo F, Moretti C, Omedè P, Cerrato E, Cavallero E, Er F, Presutti DG, Colombo F, Crimi G, Conrotto F, Dinicolantonio JJ, Chen S, Prasad A, Biondi Zoccai G, Gaita F. Cardiac remote ischaemic preconditioning reduces periprocedural myocardial infarction for patients undergoing percutaneous coronary interventions: a meta-analysis of randomised clinical trials. EuroIntervention. 2014;9(12):1463-71. doi: 10.4244/EIJV9I12A244. Review. — View Citation

Ghaemian A, Nouraei SM, Abdollahian F, Naghshvar F, Giussani DA, Nouraei SA. Remote ischemic preconditioning in percutaneous coronary revascularization: a double-blind randomized controlled clinical trial. Asian Cardiovasc Thorac Ann. 2012 Oct;20(5):548-54. doi: 10.1177/0218492312439999. — View Citation

Hausenloy DJ, Mwamure PK, Venugopal V, Harris J, Barnard M, Grundy E, Ashley E, Vichare S, Di Salvo C, Kolvekar S, Hayward M, Keogh B, MacAllister RJ, Yellon DM. Effect of remote ischaemic preconditioning on myocardial injury in patients undergoing coronary artery bypass graft surgery: a randomised controlled trial. Lancet. 2007 Aug 18;370(9587):575-9. — View Citation

Hu S, Dong HL, Li YZ, Luo ZJ, Sun L, Yang QZ, Yang LF, Xiong L. Effects of remote ischemic preconditioning on biochemical markers and neurologic outcomes in patients undergoing elective cervical decompression surgery: a prospective randomized controlled trial. J Neurosurg Anesthesiol. 2010 Jan;22(1):46-52. doi: 10.1097/ANA.0b013e3181c572bd. Erratum in: J Neurosurg Anesthesiol. 2010 Apr;22(2):157. — View Citation

Liu Z, Wang YL, Hua Q, Chu YY, Ji XM. Late remote ischemic preconditioning provides benefit to patients undergoing elective percutaneous coronary intervention. Cell Biochem Biophys. 2014 Sep;70(1):437-42. — View Citation

Meng R, Asmaro K, Meng L, Liu Y, Ma C, Xi C, Li G, Ren C, Luo Y, Ling F, Jia J, Hua Y, Wang X, Ding Y, Lo EH, Ji X. Upper limb ischemic preconditioning prevents recurrent stroke in intracranial arterial stenosis. Neurology. 2012 Oct 30;79(18):1853-61. doi: 10.1212/WNL.0b013e318271f76a. — View Citation

Schmidt MR, Sloth AD, Johnsen J, Bøtker HE. Remote ischemic conditioning: the cardiologist's perspective. J Cardiovasc Med (Hagerstown). 2012 Nov;13(11):667-74. doi: 10.2459/JCM.0b013e328357bff2. Review. — View Citation

Shimizu M, Saxena P, Konstantinov IE, Cherepanov V, Cheung MM, Wearden P, Zhangdong H, Schmidt M, Downey GP, Redington AN. Remote ischemic preconditioning decreases adhesion and selectively modifies functional responses of human neutrophils. J Surg Res. 2010 Jan;158(1):155-61. doi: 10.1016/j.jss.2008.08.010. — View Citation

Szijártó A, Czigány Z, Turóczi Z, Harsányi L. Remote ischemic perconditioning--a simple, low-risk method to decrease ischemic reperfusion injury: models, protocols and mechanistic background. A review. J Surg Res. 2012 Dec;178(2):797-806. doi: 10.1016/j.jss.2012.06.067. Review. — View Citation

Tobis J. Is no-no-reflow following PCI in AMI due to distal embolization of plaque and thrombus? Catheter Cardiovasc Interv. 2013 Aug 1;82(2):210-1. doi: 10.1002/ccd.25078. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiovascular events		one year	No