A Non-invasive Index of Microciculatory Resistance

NCT ID: NCT04554004

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-15
• Study Completion Date: 2024-12-31

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.

Conditions

Coronary Microvascular Disease; Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

All consecutive patients undergoing outine CT angiography and dynamic CT-myocardial perfusion imaging(MPI) will be potentially eligible for inclusion in the trial. Assessment of coronary stenosis severity using invasive fractional flow reserve (FFR) and the status of myocardial microcirculation perfusion including coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed as part of invasive coronary angiography(CAG).

Group Type: EXPERIMENTAL

CCTA, CT-MPI, DSA, FFR

Intervention Type: DIAGNOSTIC_TEST

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)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Jinyu Huang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First People's Hospital of Hangzhou

Hanzhou, Zhejiang, China

Countries

China

Other Identifiers

2020C03018

Identifier Type: -

Identifier Source: org_study_id