A Non-invasive Index of Microciculatory Resistance

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Coronary Microvascular Disease
• Intervention / Treatment: Diagnostic test: CCTA, CT-MPI, DSA, FFR

• Study Type: Interventional
• Enrollment (Estimated): 295
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beibei Gao; Phone Number: 8615858114771; Email: beier05@126.com

Study Locations

• China
  • Zhejiang
    • Hanzhou, Zhejiang, China
      • Recruiting
      • First People's Hospital of Hangzhou
      • Contact: Xi Lv; Phone Number: 0571-56007418

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensitivity and specificity	The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: First People's Hospital of Hangzhou

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 12, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Angina Pectoris; Coronary Artery Disease; Microvascular Angina
• Other Study ID Numbers: 2020C03018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article after deidentification (text, table, figures, and appendices).
• IPD Sharing Time Frame: When will data be available (start and end dates)?Beginning 3 months. No end data.
• IPD Sharing Access Criteria: Proposals should be directed to zdsyhjy0902@zju.edu.cn. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No