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

NCT ID: NCT02843464

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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long-term RIPC group

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.

Group Type EXPERIMENTAL

reported remote ischemic preconditioning (RIPC)

Intervention Type OTHER

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

control group

routine treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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reported remote ischemic preconditioning (RIPC)

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Zhi Liu, doctor

Role: CONTACT

+8613911517967

References

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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.

Reference Type BACKGROUND
PMID: 23878032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24156966 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23114270 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22868050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23087298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20189026 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17707752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19540519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19996767 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23035060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24755386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25015066 (View on PubMed)

Other Identifiers

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XuanwuH-RIPC2

Identifier Type: -

Identifier Source: org_study_id

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