Comprehensive Functional Assessments for NOCAD

NCT ID: NCT06175572

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2022-12-31

Brief Summary

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To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.

Detailed Description

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Conditions

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Coronary Artery Disease Myocardial Ischemia Coronary Microvascular Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NCF cohort

Normanl coronary-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).

coronary physiological indices

Intervention Type DEVICE

coronary physiological indices

CSF cohort

Coronary slow-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).

coronary physiological indices

Intervention Type DEVICE

coronary physiological indices

ANOCA cohort

Angina with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).

coronary physiological indices

Intervention Type DEVICE

coronary physiological indices

INOCA cohort

Ischemia with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT).

coronary physiological indices

Intervention Type DEVICE

coronary physiological indices

Interventions

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coronary physiological indices

coronary physiological indices

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
2. CZT-SPECT was successfully conducted within three days of CAG

Exclusion Criteria

1. had flow-limiting epicardial stenosis (DS% \>50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
2. severe valvular heart disease;
3. chronic heart failure and/or left ventricular ejection fraction (LVEF) of \< 50%;
4. cardiomyopathy and myocarditis;
5. severe renal or hepatic insufficiency;
6. failure in detecting SPECT;
7. failure in computing Angio-IMR, and -FFR.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Junbo Ge

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chenguang Li

Role: STUDY_DIRECTOR

Fudan University

Locations

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Zhongshan hospital, Fudan university

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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ZS20231202

Identifier Type: -

Identifier Source: org_study_id