A Non-invasive Index of Microciculatory Resistance

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance

Conditions
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Coronary Artery Disease, Coronary Microvascular Disease

Intervention / Treatment
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* Diagnostic Test: CCTA, CT-MPI, DSA, FFR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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). | Diagnostic Test: CCTA, CT-MPI, DSA, FFR<br>* The patients who enrolled the study will undergo coronary CT angiography(CCTA), dynamic CT-MPI, invasive coronary angiography and invasive computation of fractional flow reserve (FFR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity and specificity | The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic | To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction. | up to 12 months |