CTRI/2013/04/003536招募中2 期
Study of Stem cell therapy in patients with myocardial infarction and persistent total occlusion of infarct related artery - COAT( Cell Therapy in Occluded arteries treatment)
Indian Council Of Medical Research New Delhi India0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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
入选标准
- •Inclusion criteria
- •1. Recent MI (3-28 d)
- •2. Obstructed artery needing intervention
- •3. consent for stem cell therapy
- •Exclusion criteria
- •1. Left main disease or TVD needing surgery
- •2. Hypotension
- •3. Consent not given
排除标准
- •. Patients with significant proximal 3-vessel or left main disease are excluded regardless of functional test results.
- •2. Patients with post-MI rest angina are not eligible
- •3. Age <18 yrs
- •4. Clinical indication for revascularization
- •5. Serious illness such as cancer or pulmonary disease that limits
- •3-year survival
- •6. Severe renal disease defined as serum creatinine ≥3.0 mg/dL
- •that markedly increases risk of radiographic contrast
- •7. Severe valvular disease
- •8. History of anaphylaxis to radiographic contrast
- •9. Infarct artery too small (reference segment diameter <2.5 mm),
- •target segment within or beyond extreme tortuosity (>90º angulation),
- •or otherwise technically a poor candidate for PCI
- •10 Chronic occlusion of IRA (seen on angiogram obtained before
- •index MI or angiographic evidence of chronicity, eg, presence
- •of bridging collaterals)
- •11. NYHA classes III-IV CHF; patients may be treated for acute
- •heart failure complicating MI and rescreened
- •12. Cardiogenic shock or sustained hypotension: systolic BP ≤90 mm Hg
- •or cardiac index ≤2.2 L/min per m2
- •13. LV aneurysm in the same location as index MI and present before
- •14. Inability to cooperate with the protocol
- •15. Patient refusal or inability to give informed consent
- •16. Refusal of patient?s physician to allow patient to participate
- •17. Pregnancy
- •18. Contraindication to anticoagulation during PCI or to routine
- •antiplatelet therapy after stent implantation
- •19. Qualifying IRA that has been grafted previously; patients with
- •prior CABG may be enrolled if the IRA was not previously grafted. Dilated or hypertrophic cardiomyopathy
研究者
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