跳至主要内容
临床试验/NCT05686707
NCT05686707招募中不适用

Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease

Federico II University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年7月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
(SAQ-7)

研究概览

简要总结

The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).

详细描述

After administration of unfractionated heparin (100UI/Kg), a special pressure guide (Pressure Wire X, Abbott), equipped with a distal sensor capable of measuring pressure and temperature, will be introduced inside the anterior descending branch (IVA) of the left coronary artery and hyperemia will be induced by intravenous infusion of adenosine. The IMR will be calculated using the thermodilution technique, and is given by the product between the mean distal pressure, in the left anterior descending coronary artery, and the mean transit time (Tmn) during maximal hyperemia.

During the procedure, additional coronary physiological indices will be calculated such as:

  • Quiescent full cycle flow ratio (RFR), - Fractional flow reserve (FFR),
  • Coronary flow reserve (CFR)

In order to identify different phenotypes of microvascular dysfunction, as follows:

  • Phenotype A: Patients with IMR>25, CFR <2 and FFR>0.80 (concordant pure-microvascular pathological results)
  • Phenotype B: patients with IMR>25, CFR>2 and FFR>0.80 (increased microvascular hyperemic resistance, maintenance of microvascular reactivity)
  • Phenotype C: Patients with IMR 25, CFR 2 and FFR>0.80 (normal hyperemic resistance and reduced reactivity) All these phenotypes can also be combined with pathological FFR measures (<0.80) (phenotypes A1, B1, C1).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients who meet all of the following criteria will be considered for study participation:
  • •Age ≥18 and <85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials
  • •Availability of the following measurements:
  • •Microvascular resistance index (IMR)
  • •Quiescent full cycle flow ratio (RFR),
  • •fractional flow reserve (FFR),
  • •Coronary flow reserve (CFR) Willingness to participate and sign the informed consent document prior to the procedure.

排除标准

  • •At least one of the following:
  • •Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation.
  • •Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine >2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.

结局指标

主要结局

(SAQ-7)

时间窗: 12 months

Identify different phenotypes of microvascular dysfunction and their associations with anginal symptom severity assessed through the Seattle Angina Questionnaire (SAQ-7).

次要结局

  • characterization of the severity of angina(12 months)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Esposito

Full Professor

Federico II University

研究点 (1)

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