NCT04554004Completed
A Non-invasive Index of Microciculatory Resistance
A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance
Source: ClinicalTrials.gov · Last updated 4 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 295 (actual)
- First submitted
- 8 Sept 2020
- Start date
- 15 Dec 2022
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- First People's Hospital of Hangzhou
- Diseases
- Coronary artery disease
- NCT number
- NCT04554004
What you commit to
- Study type: Interventional
- Participants enrolled: 295
- From 15 Dec 2022 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous PCI or CABG
Other illness
- Complicated complex congenital heart disease
- Implanted artificial heart valve
- Severe arrhythmia including complete AV block, ventricular arrhythmia
- Allergic to iodine
- 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)
Lab values
- Impaired chronic renal function (serum creatinine\>1.5ULN)
Other
- Subject is not eligible for measuring IMR
- Artificial pacemaker or internal defibrillator leads implanted
- Pregnancy
- Body mass index \>35 kg/m2
- Left ventricle is markedly thickened
- Needs for emergency procedures
- Severe distortion of in the blood vessel
- Others who are inappropriate subject judged by clinician
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First People's Hospital of Hangzhou Coordinator of this site? Confirm its status | Hanzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.