Non-invasive assessment of coronary microcirculation resistance
A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance
NA · First People's Hospital of Hangzhou · NCT04554004
This study is testing a new, non-invasive way to diagnose coronary microvascular disease by measuring blood flow in the tiny vessels of the heart to help improve treatment for heart conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 295 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First People's Hospital of Hangzhou (other) |
| Locations | 1 site (Hanzhou, Zhejiang) |
| Trial ID | NCT04554004 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a non-invasive method for diagnosing coronary microvascular disease (CMVD) by establishing a coronary microcirculation resistance index (CT-IMR). It involves creating a three-dimensional reconstruction of coronary arteries and utilizing computational fluid mechanics to assess microcirculation. The study includes both single-center and multi-center clinical verifications to evaluate the precision of this new assessment system. The goal is to improve the diagnosis and treatment of coronary artery disease by enhancing the understanding of myocardial microcirculation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are indicated for invasive coronary angiography.
Not a fit: Patients with previous coronary interventions, severe arrhythmias, or life-threatening conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable non-invasive diagnostic tool for coronary microvascular disease, improving patient outcomes.
How similar studies have performed: While there is ongoing research in non-invasive assessments of coronary microcirculation, this specific approach appears to be novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hanzhou, Zhejiang
- First People's Hospital of Hangzhou — Hanzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Beibei Gao
- Email: beier05@126.com
- Phone: 8615858114771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Microvascular Disease, Coronary Artery Disease