CTRI/2017/08/009537招募中未知
Comparison of resting and hyperemic pressure indices of coronary physiology in intermediate coronary lesions â?? A prospective Multicenter Study
Dr Ajit Mullasari S0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.All patient should be more than 18 years of age
- •2.They must be patients of stable angina or acute coronary syndromes (only non-culprit vessels and >48 h from symptoms onset in the case of myocardial infarction) taken up for invasive coronary angiography with or without percutaneous coronary intervention.
- •3.The coronary lesions considered for pressure studies must be ranging from 40-70% diameter stenosis in 1 or more native major epicardial vessel or its branches, at least 2 mm in diameter, as estimated by visual assessment.
排除标准
- •1.Patients with significant valvular pathology, previous coronary artery bypass surgery, coronary thrombus at the site of lesion, or in-stent restenosis.
- •2.Patients with ejection fraction <40% measured by 2D echocardiography, regional wall motion abnormality in the area subtended by the intermediate coronary lesion, prior to the angiographic study.
- •3.Extremely tortuous coronary arteries
- •4.Severely calcified coronary arteries
- •5.Left main coronary artery disease
- •6.Occluded coronaries
- •7.Patients with history of asthma/COPD or other contraindication to adenosine
- •8.Patients with history of contrast allergy
- •9.Patients with kidney diseases with derangements in eGFR <60 ml/mt
- •10.Patients with hypotension, systolic blood pressure <90mmHg at time of study
- •11.Patients with arrhythmias like ventricular tachyarrhythmia
- •12.Patients who are unwilling to participate in the study or sign the informed consent
- •13.Patients with the following during the core laboratory analysis also will be excluded from the study: inappropriate normalization of the pressure wire (Pd/Pa ratio <0.98 or >1.02), ECG artefacts or significant arrhythmias in the first 20 s of the recording (â??iFR calculation windowâ??), loss of Pa or Pd signals at any point during the recording, automatic calculation pitfalls (identification of FFR during ectopic beats, Pa or Pd noise, wire whipping artefacts, and so on), dampening of Pa or Pd waveforms, pressure drift higher than <0.98 or >1.02, and absence of ECG or pressure-pullback recording.
研究者
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