Long-term Remote Ischemic Preconditioning Improve Long-term Prognosis of Acute Myocardial Infarction Patients Without Emergency Reperfusion Therapy

NCT02843464 | Unknown

• 1 other identifier: XuanwuH-RIPC2
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with acute myocardial infarction (AMI) are in critical condition especially without emergency reperfusion therapy. For example, heart failure, heart rupture, malignant arrhythmia are in high level. It was reported remote ischemic preconditioning (RIPC) may play an effective endogenous cardiac protection. This study will investigate whether long-term RIPC can improve the short-term and long-term (1 year) prognosis of AMI patients without emergency reperfusion therapy. 220 AMI patients without emergency reperfusion therapy were randomly divided into 2 groups: long-term RIPC group (once RIPC/day for a year) or control group (routine treatment). 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 in hospital, 1 month and 1 year after discharge. 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.

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.

  one year

Study Arms (2)

long-term RIPC group

EXPERIMENTAL

routine treatment + once RIPC/day for a year. Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

Other: reported remote ischemic preconditioning (RIPC)

control group

NO INTERVENTION

routine treatment.

Interventions

reported remote ischemic preconditioning (RIPC) OTHER

Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.

long-term RIPC group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-80 years;
• Acute myocardial infarction (STEMI);
• Without emergency reperfusion therapy.

You may not qualify if:

• Age more than 80 or less than 18 years;
• Renal failure with creatinine \>2 mg/dl;
• Reject taking part in the study.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Related Publications (12)

• 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. No abstract available.

  PMID: 23878032 BACKGROUND

• 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.

  PMID: 24156966 BACKGROUND

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

  PMID: 23114270 BACKGROUND

• Szijarto A, Czigany Z, Turoczi Z, Harsanyi 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. Epub 2012 Jul 28.

  PMID: 22868050 BACKGROUND

• 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.

  PMID: 23087298 BACKGROUND

• Botker HE, Kharbanda R, Schmidt MR, Bottcher 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, Sorensen 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.

  PMID: 20189026 BACKGROUND

• 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. doi: 10.1016/S0140-6736(07)61296-3.

  PMID: 17707752 BACKGROUND

• 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.

  PMID: 19540519 BACKGROUND

• 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.

  PMID: 19996767 BACKGROUND

• 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. Epub 2012 Oct 3.

  PMID: 23035060 BACKGROUND

• D'Ascenzo F, Moretti C, Omede 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.

  PMID: 24755386 BACKGROUND

• 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. doi: 10.1007/s12013-014-9936-1.

  PMID: 25015066 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Zhi Liu, doctor

CONTACT

+8613911517967; xwyy168@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2018
• Last Updated: January 12, 2017

Record last verified: 2016-07