A Non-invasive Index of Microciculatory Resistance

Zhejiang University

Status: Completed

Conditions: Coronary Artery Disease; Coronary Microvascular Disease

Treatments: Diagnostic Test: CCTA, CT-MPI, DSA, FFR

Study type: Interventional

Funder types: Other

Identifiers

NCT04554004

2020C03018

Details and patient eligibility

About

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.

Enrollment: 295 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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295 participants in 1 patient group

Study group

Experimental group

Description:

All consecutive patients undergoing outine CT angiography and dynamic CT-myocardial perfusion imaging(MPI) will be potentially eligible for inclusion in the trial. Assessment of coronary stenosis severity using invasive fractional flow reserve (FFR) and the status of myocardial microcirculation perfusion including coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed as part of invasive coronary angiography(CAG).

Treatment:

Diagnostic Test: CCTA, CT-MPI, DSA, FFR