NCT02313987撤回不适用
The Impact of Endothelial Function-guided Therapy Compared to Usual Care on Major Adverse Cardiovascular Events in Patients With Chest Pain and Non-obstructive Coronary Artery Disease
Itamar-Medical, Israel2 个研究点 分布在 1 个国家开始时间: 2015年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- MACE
研究概览
简要总结
The current study is designed to test the hypothesis that compared to conventional treatment; endothelial function-guided treatment reduces adverse cardiovascular events in patients with non-obstructive coronary artery disease documented at clinically indicated coronary angiography.
详细描述
Subjects with chest pain and non-obstructive coronary artery disease (20-70% luminal diameter narrowing) documented by coronary angiograms will be enrolled in the study 2 - 30 days following the coronary angiograms. Only subjects who have signed an Informed Consent Form and meet all of the eligibility criteria will be qualified for enrollment.
Following the baseline EndoPAT testing subjects will be divided into two groups by their EndoPAT (EndoScore) results:
- Group A - normal EndoScore: Logarithmic value of RHI (Ln_RHI) >0.7
- Group B - abnormal EndoScore: Ln_RHI ≤ 0.7 The subjects of Group B will be randomized in 1:1 ratio (by envelopes with randomization numbers at each site) to Group B1 who will be treated conventionally i.e., "usual care" by the site study team; and Group B2 who will be treated with "enhanced care".
Staff prescribing treatment regime for subjects in group A and B1 ("usual care") along with the subjects in these groups, will be blinded to the EndoScore value.
Subjects of all groups will return for 4 follow-up visits: 180±14days, 360±14days, 720±14days and 1080±14days (study end).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with chest pain and non-obstructive coronary artery disease documented by coronary angiography with 20-70% luminal diameter stenosis that does not justify coronary revascularization
- •Stable subjects without evidence of prior MI/CABG/PTCA.
- •Age 20 to 79 years
- •Ability to understand the study procedures and provide written informed consent
- •Willingness and ability to comply with the study and its scheduled visits and study procedures
排除标准
- •Age below 20 over 79 years
- •Subjects with documented MI, PTCA or CABG
- •Unstable angina
- •Any lesion > 20% luminal narrowing in the left main coronary artery
- •Congestive heart failure, NYHA class II - IV
- •Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR calculated by MDRD) < 20 mL/min/1.73m2 at screening
- •Uncontrolled hyperthyroidism or hypothyroidism as defined by thyroid stimulating hormone (TSH) , 1.0 time the lower limit of normal (LLN) or > 1.5 times the upper limit of normal (ULN), respectively, at screening
- •Symptomatic peripheral artery disease
- •History of drug or alcohol abuse
- •Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 2 times the ULN as determined by local laboratory analysis at screening
- •Prior CVA or TIA
- •Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ or stage 1 prostate carcinoma) with life expectancy of < 3 years
- •Any planned surgery within 3 months after randomization
- •Recipient of any major organ transplant (e.g., heart, lung, liver, bone marrow)
- •Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years
- •Known, concerning active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the investigator
- •Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s). Special clearance can be obtained from the Steering Committee for subjects enrolled in studies not conflicting with this protocol
- •History or evidence of any other clinically significant disorder, condition or disease other than those outlined above that, in the opinion of the investigator may compromise the ability of the subject to give written informed consent, would pose a risk to the subject safety, or interfere with the study evaluation, procedures or completion
- •Deformities of the digits of the upper extremities, which preclude adequate signal acquisition
- •Subjects under the effect of short-acting NTG (3 hours washout period)
- •Patient suffering from a medical condition prohibiting blood flow occlusion in both arms
结局指标
主要结局
MACE
时间窗: 3 years
Time to the first occurrence of death, cardiovascular death, non-fatal myocardial infarction, stroke, transient ischemic attack, coronary revascularization, or hospitalization for congestive heart failure.
次要结局
- quality of life questionnaire(3years)
- myocardial infarction(3 years)
- Rehospitalization for chest pain(3 years)
- time to the first occurrence of cardiovascular death(3 years)
- Stroke(3 years)
- time to the first occurrence of death from any cause(3 years)
- hospitalization for worsening heart failure(3 years)
- time to the first occurrence of ischemic fatal or non-fatal stroke or transient ischemic attack.(3 years)
研究者
研究点 (2)
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