Back to results

A Non-invasive Index of Microciculatory Resistance

Primary Purpose

Coronary Microvascular Disease, Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CCTA, CT-MPI, DSA, FFR

About this trial

This is an interventional diagnostic trial for Coronary Microvascular Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

First People's Hospital of HangzhouRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

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).

Outcomes

Primary Outcome Measures

sensitivity and specificity

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

Secondary Outcome Measures

diagnostic

To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction.

Full Information

NCT ID

NCT04554004

First Posted

September 8, 2020

Last Updated

August 14, 2023

Sponsor

First People's Hospital of Hangzhou

1. Study Identification

Unique Protocol Identification Number

NCT04554004

Brief Title

A Non-invasive Index of Microciculatory Resistance

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 15, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First People's Hospital of Hangzhou

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Microvascular Disease, Coronary Artery Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

295 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

CCTA, CT-MPI, DSA, FFR

Intervention Description

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)

Primary Outcome Measure Information:

Title

sensitivity and specificity

Description

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

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

diagnostic

Description

To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction.

Time Frame

up to 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beibei Gao

Phone

8615858114771

beier05@126.com

Facility Information:

Facility Name

First People's Hospital of Hangzhou

City

Hanzhou

State/Province

Zhejiang

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xi Lv

Phone

0571-56007418

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

A Non-invasive Index of Microciculatory Resistance

We'll reach out to this number within 24 hrs