Does COlchicine Improve EnDothElial Function in Non ST Elevation Myocardial Infarction Patients?: A Prospective Randomized, Double-blind Placebo Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Improvement of RH-PAT at 1 month (a marker of endothelial function)
研究概览
简要总结
Colchicine has antiinflammatory properties. It has been shown to be effective in improving outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to assess the effect of colchicine on endothelial function using the EndoPAT™ in NSTEMI Patients.
Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients who were in treated with colchicine versus the placebo group Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction will be enrolled to a prospective randomized double-blind placebo controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their hospitalization before cardiac catheterization. All patients will sign an informed consent.
Primary outcome will be the improvement in endothelial function between baseline and after 1 month in both groups
详细描述
Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction (NSTEMI) will be enrolled to a prospective randomized double-blind placebo controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their hospitalization before cardiac catheterization. All patients will sign an inform consent. Study will be published on NIH clinicaltrials.com database.
Inclusion and exclusion criteria are presented in Table 1 Table 1: Patient Selection Inclusion criteria
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NSTEMI Diagnosis 2. Patients above the age of 18 3. Informed consent Exclusion criteria
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Hemodynamic instability
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Pregnant women
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Peripheral vascular disease with feeble or absent peripheral pulses
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Restlessness and/or chaotic breathing
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Renal dialysis
-
Severe aortic valve insufficiency/Stenosis
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Severe mitral valve insufficiency
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Congenital cardiac malformations (structural heart diseases)
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Known extra-cardiac shunts
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Major surgery within 30 days
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Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
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Known intolerance to colchicine
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Ejection fraction less than 35% or past admission for CHF exacerbation in the last 30 days.
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Inflammatory diseases
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Current treatment with steroids, NSAID, chemotherapy or biologic medications
Pre Study exam
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSTEMI Diagnosis
- •Patients above the age of 18
- •Informed consent
排除标准
- •Hemodynamic instability
- •Pregnant women
- •Peripheral vascular disease with feeble or absent peripheral pulses
- •Restlessness and/or chaotic breathing
- •Renal dialysis
- •Severe aortic valve insufficiency/Stenosis
- •Severe mitral valve insufficiency
- •Congenital cardiac malformations (structural heart diseases)
- •Known extra-cardiac shunts
- •Major surgery within 30 days
- •Any medical condition that would impair participation (e.g. progressive neurological disorders, mental illness)
- •Known intolerance to colchicine
- •Ejection fraction less than 35% or past admission for CHF exacerbation in the last 30 days.
- •Inflammatory diseases
- •Current treatment with steroids, NSAID, chemotherapy or biologic medications
研究组 & 干预措施
Colchicine
Colchicine 1mg per day for one month
干预措施: Colchicine (Drug)
Placebo
Placebo 1mg per day
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement of RH-PAT at 1 month (a marker of endothelial function)
时间窗: 1 month
RH-PAT will be measured before the angiography and after one month.
次要结局
- Reduction of peri-procedural myocardial infarction(1 month)
- Improvement in endothelial function markers.(1 month)
- Improvement in inflammatory biomarkers (before cardiac catheterization, after cardiac catheterization and at 1 month time follow-up)(1 month)
- Changes in cholinergic status(1 month)
- Reduction in radial artery occlusion(acute)
- inflammatory biomarkers Improvement of heart rate variability (HRV)(1 month)
- Reduction of Acute Kidney Injury post PCI(1 month)
- Major adverse clinical events (MACE) defined as a composite of all-cause mortality, myocardial infarction, repeat revascularization, and 30 day readmission rate(1 month)
- quality of life under colchicine treatment(1 month)
- Safety(up to 1 year)
研究者
michal roll
Tel-Aviv Medical Center
Tel-Aviv Sourasky Medical Center