Coronary Artery DiseaseCONCORDENCT06127420
Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- coronary physiological indices
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2023to Nov 2024
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A all-comer population of patients with suspected coronary artery disease referred to invasive angiography at Zhongshan Hospital.
Who may be able to join
- suspected coronary artery disease
- referred to invasive coronary angiography
Who cannot join
- hemodynamic instability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices in Patients Referred to Angiography
The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and health care providers about which technologies are most effective and efficient in the diagnosis and management of coronary artery diseases.
Read the detailed description
CONCORDE registry offers a comprehensive pressure and/or flow measurements, as well as angiography-derived functional assessment of coronary. Patient treatment was at the operator's discretion at the time of the invasive procedure. A standardized data collection sheet was used and data were extracted from electrical medical history according to standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data.
- Conditions
- Coronary Artery Disease
- Being tested
- coronary physiological indices
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary physiological indicesOther
Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Resting full-cycle ratio, Coronary Flow Reserve, Microvascular resistance
| Study group | Role | What they receive |
|---|---|---|
| All patients | All patients referred to angiography and undergo assessment with coronary pressure sensor Receives: Other: 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)
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
Measured: 5 years
Secondary outcomes (2)
Target vessel failure (TVF)
Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
Measured: 5 years
Individual components of MACE and TVF
Cumulative incidence of the individual components of MACE and TVF
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 posted13 Nov 2023
- Study start6 Dec 2023
- Primary completion7 May 2024
- Study completionNov 2024 (estimated)
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.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 3,000 participants (estimated)
- 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, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127420
- Sponsor's protocol ID
- ZSCD2023001
- Acronym
- CONCORDE
- Status last verified
- May 2024
- First submitted
- 7 Nov 2023
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Assessment on Diagnostic and Prognostic Performance of Coronary Physiological Indices in Patients Referred to Angiography
- ClinicalTrials.gov ID
- NCT06127420
- Acronym / sponsor ID
- CONCORDE / ZSCD2023001
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 13 Nov 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.
The objective of the Zhongshan Hospital CONCORDE Registry is to evaluate utility, diagnostic value, and clinical outcomes of coronary physiological indices in an all-comers population of patients with suspected coronary artery disease referred to invasive coronary angiography in order to further inform patients and health care providers about which technologies are most effective and efficient in the diagnosis and management of coronary artery diseases.
Detailed description
CONCORDE registry offers a comprehensive pressure and/or flow measurements, as well as angiography-derived functional assessment of coronary. Patient treatment was at the operator's discretion at the time of the invasive procedure. A standardized data collection sheet was used and data were extracted from electrical medical history according to standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: coronary physiological indicesAll patients referred to angiography and undergo assessment with coronary pressure sensor |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A all-comer population of patients with suspected coronary artery disease referred to invasive angiography at Zhongshan Hospital.
Key inclusion criteria (2 listed)
- suspected coronary artery disease
- referred to invasive coronary angiography
Key exclusion criteria (1 listed)
- hemodynamic instability
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 indicesResting distal coronary to aortic pressure ratio, Fractional flow reserve, Resting full-cycle ratio, Coronary Flow Reserve, Microvascular resistance | Other | All patients |
Primary outcome
Major adverse cardiac events (MACE)
Time frame: 5 years
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
2 secondary outcomes
Target vessel failure (TVF)
Time frame: 5 years
Individual components of MACE and TVF
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- 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
Shanghai Zhongshan Hospital
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, 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 1 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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?
Results are not available in the source record.
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 9 May 2024.