PACTR202112803123592尚未招募3 期
Remote Ischaemic Conditioning in STEMI patients in sub-Saharan AFRICA: The RIC-AFRICA trial
niversity of Cape Town0 个研究点目标入组 1,200 人开始时间: 2021年11月29日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Eligible patients
- •1. Adult patients (=18 years old) presenting with STEMI receiving thrombolytic therapy within guideline-recommended time (i.e., within ±12 hours of most severe chest pain onset).
- •2. Adult patients (=18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time (>12 hours) but within 24 hours of most severe chest pain onset.
- •3. Adult patients (=18 years old) presenting with evidence of STEMI who do not receive thrombolysis and who present =24 hours and within 72 hours of most severe chest pain onset.
- •Interventional arm of the study: Randomized Control Trial
- •Patients who are deemed eligible for randomization into the trial on account of presentation with STEMI within 24 hours, will be eligible for the interventional arm of the study if the following inclusion/exclusion criteria are met.
- •Inclusion criteria
- •I. Adult patients (=18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads, i.e., = 0.2mV in men =40 years (=0.25 mV in men <40 years); or = 0.15mV in women in leads V2-V3 and/or = 0.1mV in other lead); and
- •II. Within 24 hours of onset of myocardial infarction as deemed by the attending clinician; and
- •III. Signed informed consent.
- •Observational arm of the study
- •Patients who are deemed ineligible for randomization into the trial on account of presentation beyond 24 hours, will be eligible for the observational arm of the study if the following inclusion/exclusion criteria are met.
- •Inclusion Criteria
- •I. Signed informed consent; and
- •II. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:
- •a. compatible history with maximal chest pain between 24 and 72 hours prior to presentation; and
- •b. compatible biomarkers (elevated cardiac troponin); and
- •c. ECG compatible with recent STEMI; and/or
- •d. compatible echocardiography.
排除标准
- •Interventional arm of the study: Randomized Control Trial
- •Exclusion criteria
- •I. STEMI patients undergoing primary percutaneous coronary intervention;
- •II. STEMI patients presenting with cardiogenic shock or haemodynamic instability (systolic blood pressure (SBP) <90 mmHg for =30 minutes; or use of pharmacological and/or mechanical support to maintain SBP = 90 mmHg; and evidence of end-organ damage such as urine output of <30 mL/h; altered mental status; and/or serum lactate >2.0 mmol/L);
- •III. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (<12 hours);
- •IV. Conditions that preclude the use of RIC or sham-control on either arm such as:
- •a. severe active skin disease/burns on both arms; or
- •b. bilateral upper limb amputations; or
- •c. evidence of acute limb ischaemia on either arm; or
- •d. active upper limb gangrene of any digits; or
- •e. bilateral arteriovenous fistulae needed for haemodialysis; or
- •f. known breast cancer with ipsilateral lymph node involvement on the side of RIC;
- •V. Inter-current disease with an expected life expectancy of less than 24 hours.
- •Observational arm of the study
- •Exclusion criteria
- •I. Refusal or inability to sign informed consent.
研究者
相似试验
进行中（未招募）
3 期
Remote ischaemic Conditioning After Stroke Trial - 3Adults with acute ischaemic stroke presenting in Emergency Departments and Stroke Units in the UKCirculatory SystemHyperacute ischaemic strokeISRCTN63231313niversity of Nottingham1,300
已完成
2 期
Improving Tolerance to Low Blood Flow to Brain in Patients with Stroke with manual Blood Pressure MachineCTRI/2016/11/007495Wellcome Trust and DBT Indian Alliance57
已完成
不适用
Effect of Remote Ischemic Conditioning in Heart Attack PatientsST-segment Elevation Myocardial Infarction (STEMI)NCT02197117University College, London519
已完成
不适用
Treatment of the lower limb pain, which arise during the walks, for lack of circulation. Through temporary circulation interruption of upper limbs.RBR-7tf6tmHospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
招募中
不适用
REMOTE ISCHEMIC CONDITIONING FOR ACUTE ISCHEMIC STROKE Part 2JPRN-UMIN000046225Tokyo Women's Medical University400