Long-term Remote Ischemic Preconditioning Improve Long-term Prognosis of Acute Myocardial Infarction Patients Without Emergency Reperfusion Therapy
Primary Purpose
Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
reported remote ischemic preconditioning (RIPC)
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
long-term RIPC group
control group
Arm Description
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.
routine treatment.
Outcomes
Primary Outcome Measures
The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.
Secondary Outcome Measures
Full Information
NCT ID
NCT02843464
First Posted
July 21, 2016
Last Updated
January 10, 2017
Sponsor
Xuanwu Hospital, Beijing
1. Study Identification
Unique Protocol Identification Number
NCT02843464
Brief Title
Long-term Remote Ischemic Preconditioning Improve Long-term Prognosis of Acute Myocardial Infarction Patients Without Emergency Reperfusion Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xuanwu Hospital, Beijing
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
long-term RIPC group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
routine treatment.
Intervention Type
Other
Intervention Name(s)
reported remote ischemic preconditioning (RIPC)
Intervention Description
Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
Primary Outcome Measure Information:
Title
The major adverse cardiovascular events (MACE) include cardiovascular death, spontaneous myocardial infarction, unplanned revascularization and stroke.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Liu, doctor
Phone
+8613911517967
Email
xwyy168@sina.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
23878032
Citation
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Citation
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Citation
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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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