A Non-invasive Index of Microciculatory Resistance

NCT04554004 | Completed

• 1 other identifier: 2020C03018
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• sensitivity and specificity

  The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.

  up to 12 months

Secondary Outcomes (1)

• diagnostic

  up to 12 months

Study Arms (1)

Study group

EXPERIMENTAL

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).

Diagnostic Test: CCTA, CT-MPI, DSA, FFR

Interventions

CCTA, CT-MPI, DSA, FFR 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)

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

First People's Hospital of Hangzhou

Hanzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Microvascular Angina; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: September 18, 2020
• Study Start: December 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: When will data be available (start and end dates)?Beginning 3 months. No end data.
• Access Criteria: Proposals should be directed to zdsyhjy0902@zju.edu.cn. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)