Coronary Artery DiseaseNCT06175572
Comprehensive Functional Assessments for NOCAD
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia, Coronary Microvascular Dysfunction
- What is being tested?
- coronary physiological indices
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population enrolled from Zhongshan Hospital, Fudan University (Shanghai, China)，with coronary angiography and available cadmium zinc telluride - single photon emission computed tomography imaging (CZT-SPECT).
Who may be able to join
- visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
- CZT-SPECT was successfully conducted within three days of CAG
Who cannot join
- had flow-limiting epicardial stenosis (DS% >50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
- severe valvular heart disease;
- chronic heart failure and/or left ventricular ejection fraction (LVEF) of < 50%;
- cardiomyopathy and myocarditis;
- severe renal or hepatic insufficiency;
- failure in detecting SPECT;
- failure in computing Angio-IMR, and -FFR.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Diagnostic and Prognostic Value of Comprehensive Functional Assessments for Non-obstructive Coronary Artery Diseases.
To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.
- Being tested
- coronary physiological indices
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary physiological indicesDevice
coronary physiological indices
| Study group | Role | What they receive |
|---|---|---|
| NCF cohort | Normanl coronary-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). Receives: 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). Receives: 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). Receives: 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). Receives: Device: coronary physiological indices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE)
The composite of coronary heart disease death, nonfatal myocardial infarction, hospitalization for unstable angina, or fatal or nonfatal ischemic stroke.
Measured: 5 years
Secondary outcomes (3)
Individual components of MACE
Cumulative incidence of the individual components of MACE
Measured: 5 years
the change in Seattle Angina Questionnaire (SAQ) summary score
The SAQ comprises 5 components namely physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life; these are then incorporated into the summary score. The higher the score, the better the patient's quality of life and physical function.
Measured: 5 years
the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale
The SAQ comprises 5 components namely physical limitation, angina stability, angina frequency, treatment satisfaction, and quality of life. The higher the score, the better the patient's quality of life or physical function.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start1 Jan 2018
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
- Investigators
- Chenguang Li, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175572
- Sponsor's protocol ID
- ZS20231202
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic and Prognostic Value of Comprehensive Functional Assessments for Non-obstructive Coronary Artery Diseases.
- ClinicalTrials.gov ID
- NCT06175572
- Acronym / sponsor ID
- ZS20231202
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NCF cohort | – | Device: coronary physiological indicesNormanl coronary-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). |
| CSF cohort | – | Device: coronary physiological indicesCoronary slow-flow patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). |
| ANOCA cohort | – | Device: coronary physiological indicesAngina with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). |
| INOCA cohort | – | Device: coronary physiological indicesIschemia with nonobstructive coronary artery patients referred to coronary angiography and undergo assessment with single photon emission computed tomography imaging (SPECT). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population enrolled from Zhongshan Hospital, Fudan University (Shanghai, China)，with coronary angiography and available cadmium zinc telluride - single photon emission computed tomography imaging (CZT-SPECT).
Key inclusion criteria (2 listed)
- visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
- CZT-SPECT was successfully conducted within three days of CAG
Key exclusion criteria (7 listed)
- had flow-limiting epicardial stenosis (DS% >50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
- severe valvular heart disease;
- chronic heart failure and/or left ventricular ejection fraction (LVEF) of < 50%;
- cardiomyopathy and myocarditis;
- severe renal or hepatic insufficiency;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary physiological indicescoronary physiological indices | Device | ANOCA cohort, CSF cohort, INOCA cohort, NCF cohort |
Primary outcome
Major adverse cardiac events (MACE)
Time frame: 5 years
The composite of coronary heart disease death, nonfatal myocardial infarction, hospitalization for unstable angina, or fatal or nonfatal ischemic stroke.
3 secondary outcomes
Individual components of MACE
Time frame: 5 years
the change in Seattle Angina Questionnaire (SAQ) summary score
Time frame: 5 years
the change in Seattle Angina Questionnaire (SAQ) score of indivadual scale
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenguang Li study director
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.