A Non-invasive Index of Microciculatory Resistance

First People's Hospital of Hangzhou295 enrolled

Overview

Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

295

Conditions

Coronary Microvascular Disease Coronary Artery Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must be older than 18 years * Written informed consent available * Subject is indicated for invasive coronary angiography * Subject need to be taken within 30 days after enrolment Exclusion Criteria: * Previous PCI or CABG * Subject is not eligible for measuring IMR * Complicated complex congenital heart disease * Artificial pacemaker or internal defibrillator leads implanted * Implanted artificial heart valve * Severe arrhythmia including complete AV block, ventricular arrhythmia * Impaired chronic renal function (serum creatinine\>1.5ULN) * Allergic to iodine * Pregnancy * Body mass index \>35 kg/m2 * Left ventricle is markedly thickened * Needs for emergency procedures * Severe distortion of in the blood vessel * Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic \< 90mmHg), severe congestive heart failure or pulmonary edema * Life-threatening diseases (life expectancy \< 2 months) * Tako Tsubo syndrome (TTS) * Others who are inappropriate subject judged by clinician

Outcomes

Primary Outcomes

sensitivity and specificity

The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.

Time frame: up to 12 months

Secondary Outcomes

diagnostic

To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction.