NCT00820586暂停2 期
Intramyocardial Delivery of Autologous Bone Marrow
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Incidence of major adverse cardiac events (MACE), defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures and peri-procedural complications.
研究概览
简要总结
A randomized study to assess the safety, feasibility and effectiveness of direct intramyocardial percutaneous delivery of autologous bone marrow-derived total mononuclear cells or selected CD34+ cells in patients with refractory angina pectoris.
详细描述
Primary Endpoint: Incidence of major adverse cardiac events (MACE) at 30 days. MACE is defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures (percutaneous or surgical), and peri-procedural complications (that is, left ventricular perforation with hemodynamic consequences requiring pericardiocentesis, and stroke).
Incidence of MACE at 3, 6 and 12 months
Secondary Endpoints:
- Change in Canadian Cardiovascular Society (CCS) angina classification score from baseline to 12 months
- Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire
- Change in exercise duration and exercise tolerance using standardized treadmill exercise testing from baseline, to 6 months and to 12 months
- Cumulative number of hospitalizations for coronary ischemia and congestive heart failure at 12 months following treatment.
- SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution for baseline to 1, 6 and 12 months
- Change in angiographic collateral score at 6 months
- Change in global and regional myocardial contractility (assessed by echocardiography) at baseline, 6 and 12 months.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe obstruction (lumen diameter stenosis > 70%) in a coronary or surgical conduit felt to be solely or partially responsible for angina and myocardial ischemia;
- •There must be at least one coronary or surgical conduit with < 70% diameter stenosis
- •Poor candidate for percutaneous coronary intervention of treatment zone
- •Poor candidates for surgical revascularization procedures, such as inadequate target coronary anatomy or lack of potential surgical conduits.
排除标准
- •Pregnant women;
- •Left ventricular ejection fraction <30% as assessed by either echocardiography or left ventriculography;
- •Severe cardiac heart failure with NYHA functional class III-IV symptoms;
- •Chronic atrial fibrillation;
- •Prosthetic aortic valve;
- •Severe (grade III-IV) mitral or aortic insufficiency;
- •Wall thickness of <8 mm (defined by echocardiography) of the proposed target region of myocardium;
- •Severe co-morbidity associated with a reduction in life expectancy of <1 year, such as chronic medical illnesses
- •Braunwald class II unstable angina
- •Severe peripheral (or aortic) vascular disease which might increase the risk of vascular complications (perforation, dissection or embolization);
- •Significant aortic valve pathologic sclerosis or stenosis
- •LV thrombus (mobile or mural-based) seen on echocardiography;
- •Recent (within 4 weeks) documented myocardial infarction (Q and/or non-Q wave) defined as CK-MB >3times upper normal level;
- •Currently enrolled in another investigational device or drug trial that has not completed the required follow-up period;
- •Thrombocytopenia or history of heparin-induced thrombocytopenia or thrombocytosis
- •Leukocytosis
- •Anemia or erythrocytosis
- •Active peptic ulcer or active gastrointestinal bleeding;
- •Chronic renal failure requiring dialysis;
- •Prior or current malignancy
- •Other conditions that can significantly affect the bone-marrow
- •Evidence of concurrent infection (WBC >12.000 mm3, temperature >38.5° C);
- •Serological of clinical evidence of HIV
- •Immunotherapy
- •Abnormal bone-marrow morphology as evident in bone-marrow smear prior to the intervention
- •Angiographic/Ventriculographic Exclusion Criteria:
- •LV thrombus (mobile or mural-based) seen on left ventriculography;
- •Coronary lesions suitable for percutaneous coronary interventions;
- •Unprotected left main coronary artery disease
结局指标
主要结局
Incidence of major adverse cardiac events (MACE), defined as a combined endpoint of death, acute MI (Q-wave and non-Q wave), revascularization procedures and peri-procedural complications.
时间窗: 1, 6, 12 months
次要结局
- Change in Canadian Cardiovascular Society (CCS) angina classification score(12 months)
- Changes in the quality of life, as assessed according to the Seattle Angina Questionnaire(1,3,6,12 months and every year for 8 years)
- Change in exercise duration and exercise tolerance using standardized treadmill exercise testing(6,12 months)
- Cumulative number of hospitalizations for coronary ischemia and congestive heart failure(12 months)
- SPECT-chances in global and regional radionuclide perfusion at rest, peak stress, and redistribution(1, 6, 12 months)
- Change in angiographic collateral score(6 months)
- Change in global and regional myocardial contractility (assessed by echocardiography)(6, 12 months)
研究者
Antonio Colombo
Director of Invasive Cardiology Unit
IRCCS San Raffaele
研究点 (2)
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