Impact of location and length of intermediate coronary stenosis on its physiological significance using fractional flow reserve and its correlation with intravascular ultrasound.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CORRELATION BETWEEN LOCATION AND LENGTH OF LESION ON ITS PHYSIOLOGICAL SIGNIFICANCE BY USING FRACTIONAL FLOW RESERVE (FFR)
研究概览
简要总结
THIS STUDY SHALL BE CONDUCTED AT A SINGLE CENTRE IN NORTHERN PART OF INDIA e.i. GOVERNMENT MEDICAL COLLEGE & HOSPITAL SECTOR 32 CHANDIGARH IN PATIENTS WITH CHRONIC STABLE ANGINA AGED MORE THAN 18 YEARS AND HAVING INDICATIONS FOR CORONARY ANGIOGRAPHY AFTER OBTAINING INFORMED CONSENT. THOSE PATIENT WHO SRE FOUND TO HAVE INTERMEDIATE CORONARY LESION SHALL FURTHER BE SUBJECTED TO FRACTIONAL FLOW RESERVE AND INTRAVASCULAR ULTRASOUND AND QCA ANALYSIS AND BARI SCORE EVALUATION. THE TRIAL PROTOCOL HAS BEEN ALREADY EVALUATED AND APPROVED BY THE RESEARCH COMMITTEE OF THE INSTITUTE AND HAS FURTHER BEEN SUBMITTED TO INSTITUTIONAL ETHICS COMMITTEE FOR FINAL APPROVAL. THE APPROVAL OF ETHICS COMMITTEE IS AVAITED VERY SOON AND THE DAY WE GET THE APPROVAL THE STUDY SHALL BE STATRED IMMEDIATELY.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •ALL PATIENTS AGED MORE THAN 18 YEARS WITH STABLE ANGINA WILLING TO PARTICIPATE IN THE STUDY AND HAVING INDICATIONS FOR CORONARY ANGIOGRAPHY AND HAVING INTERMEDIATE CORONARY STENOSIS ON ANGIOGRAPHY e.i.
- •80% SHALL BE INCLUDED IN THE STUDY FOR FUTHER EVALUATION OF THESE LESIONS BY USING FRACTIONAL FLOW RESERVE FFR TO KNOW THEIR PHYSIOLOGICAL SIGNIFICANCE AND INTRAVASCULAR ULTRASOUND SHALL ALSO BE DONE TO KNOW THE PLAQUE MORPHOLOGY AND COMPOSITION TO FINF THE CORRELATION BETWEEN FFR AND IVUS AS WELL AS QCA.
排除标准
- •1.Acute coronary syndrome (STEMI/NSTEMI/UA) 2.Culprit lesion of previous myocardial infarction 3.Previous coronary artery bypass surgery 4.Tandem lesion 5.In-stent restenosis lesion 6.Cardiogenic shock 7.Low left ventricular systolic function (LVEF < 40%) 8.Chronic Kidney Disease 9.Chronic Liver Disease 10.Pregnant females 11.Failure to obtain informed consent from participants.
结局指标
主要结局
CORRELATION BETWEEN LOCATION AND LENGTH OF LESION ON ITS PHYSIOLOGICAL SIGNIFICANCE BY USING FRACTIONAL FLOW RESERVE (FFR)
时间窗: At 1 year
次要结局
- 1.To determine the correlation between QCA, IVUS and FFR for intermediate coronary lesions.(2.To find a correlation between FFR and BARI scores used for assessment of myocardial area under jeopardy)