A Non-invasive Index of Microciculatory Resistance

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554004
• Other study ID #: 2020C03018
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Microvascular Disease
• Microvascular Angina

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