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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04554004
Other study ID # 2020C03018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2022
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source First People's Hospital of Hangzhou
Contact Beibei Gao
Phone 8615858114771
Email beier05@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 295
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
CCTA, 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)

Locations

Country Name City State
China First People's Hospital of Hangzhou Hanzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity and specificity The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied. up to 12 months
Secondary 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
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