Myocardial Infarction, Acute Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Xuanwu Hospital, Beijing |
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | major adverse cardiovascular events | one year | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05759078 -
Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion
|
Phase 4 | |
Completed |
NCT06408636 -
Prognostic Role of LA Strain in Acute Myocardial Infarction
|
||
Recruiting |
NCT06038994 -
Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
|
||
Recruiting |
NCT04968808 -
Timing of FFR-guided PCI for Non-IRA in NSTEMI and MVD (OPTION-NSTEMI)
|
N/A | |
Completed |
NCT03338504 -
Determining the Mechanism of Myocardial Injury and Role of Coronary Disease in Type 2 Myocardial Infarction
|
||
Recruiting |
NCT03317691 -
The ALERT-Pilot Study
|
N/A | |
Active, not recruiting |
NCT05077683 -
Direct Oral Anticoagulants for Prevention of lEft ventRIcular Thrombus After Anterior Acute Myocardial InFarction - APERITIF
|
Phase 3 | |
Recruiting |
NCT03957005 -
Cardiovascular Risk Assessment Model in Patients With MI
|
||
Enrolling by invitation |
NCT05955950 -
Gratitude Intervention in Promoting Self-care in Patients With Myocardial Infarction
|
N/A | |
Active, not recruiting |
NCT06141252 -
Benefit of Hypothermia in OHCA Complicating AMI
|
N/A | |
Not yet recruiting |
NCT04560023 -
Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction
|
N/A | |
Terminated |
NCT03809689 -
Study of Cardiac Lesions Angiogenesis by 68Ga-NODAGA-RGD Cardiac PET
|
N/A | |
Recruiting |
NCT06430892 -
RAPID-POP a Randomized Controlled Trial
|
N/A | |
Completed |
NCT05118009 -
Artificial Intelligence Based Rapid Identification of ST-elevation Myocardial Infarction Using Electrocardiogram (ARISE)
|
N/A | |
Active, not recruiting |
NCT04753749 -
Evaluation of a Modified Anti-Platelet Therapy Associated With Low-dose DES Firehawk in Acute Myocardial Infarction Patients Treated With Complete Revascularization Strategy
|
N/A | |
Completed |
NCT04769219 -
Secondary Prevention Education After Acute Myocardial Infarction
|
N/A | |
Active, not recruiting |
NCT05350969 -
Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction After Myocardial Infarction
|
Phase 2 | |
Recruiting |
NCT05999110 -
Algarve Active Ageing - Cardiac and Osteoarthritis Rehabilitation (A3-COR)
|
N/A | |
Completed |
NCT04167904 -
Biomarkers in Patients Hospitalized With Suspected Acute Myocardial Infarction
|
||
Not yet recruiting |
NCT04989777 -
IABP In AMI Patients With SCAI-B Study
|
N/A |