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

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ClinicalTrials.gov Identifier: NCT02843464
Recruitment Status : Unknown
Verified July 2016 by Xuanwu Hospital, Beijing.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2016
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: reported remote ischemic preconditioning (RIPC) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2016
Estimated Primary Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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.
Other: 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.

No Intervention: control group
routine treatment.



Primary Outcome Measures :
  1. The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke. [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843464


Contacts
Contact: Zhi Liu, doctor +8613911517967 xwyy168@sina.com

Sponsors and Collaborators
Xuanwu Hospital, Beijing

Publications:

Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT02843464     History of Changes
Other Study ID Numbers: XuanwuH-RIPC2
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 2016

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases