Coronary Artery Disease, Coronary Microvascular Disease
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCCTA, CT-MPI, DSA, FFR
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)
Sponsors
First People's Hospital of Hangzhou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| sensitivity and specificity | up to 12 months | The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| diagnostic | up to 12 months | To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction. |
Countries
China
Outcome results
None listed