Coronary Artery DiseaseNCT05409209
Carotid Plaque Length to Predict Cardiovascular Events
An observational study of Coronary Artery Disease, run by Changhai Hospital at 5 sites in China.
Trial summary
This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 3,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized for first coronary angiography and underwent carotid ultrasonography simultaneously
Who may be able to join
- Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.
Who cannot join
- Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Changhai Hospital
Shanghai, Shanghai Municipality, 200000
Gongli Hospital
Shanghai, Shanghai Municipality, 200000
Putuo Hospital
Shanghai, Shanghai Municipality, 200000
Yueyang Hospital
Shanghai, Shanghai Municipality, 200000
No. 904 Hospital of the PLA Joint Logistics Support Force
Wuxi, Jiangsu, 214000
About this study
This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 3000 patients for suspected CAD who referred to coronary angiography from January 2017 through December 2018.
Read the detailed description
Patients with coronary artery disease who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was performed before coronary angiography, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.
- Conditions
- Coronary Artery Disease
- Keywords
- Carotid Artery Ultrasound, Carotid Plaque, Coronary Artery Disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Carotid plaque length | Patients underwent carotid ultrasonography and first coronary angiography simultaneously |
What is being measured
The primary outcome is the main question the study is designed to answer.
major cardiovascular event
A composite of cardiovascular death, myocardial infarction, and ischemic stroke
Measured: 3 years
Secondary outcomes (6)
major vascular event
A composite of cardiovascular death, myocardial infarction, ischemic stroke, and coronary artery revascularization
Measured: 3 years
all-cause death
Measured: 3 years
cardiovascular death
Measured: 3 years
myocardial infarction
Measured: 3 years
ischemic stroke
Measured: 3 years
coronary artery revascularization
coronary artery bypass grafting or percutaneous coronary intervention
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Jan 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2030 (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 Changhai 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Putuo Hospital, Shanghai University of Traditional Chinese Medicine, 904th Hospital of the Joint Logistics Support Force of the PLA, Gongli Hospital, Yueyang Hospital, Shanghai University of Traditional Chinese medicine
- Responsible party
- Principal investigator, Pan Li, Changhai Hospital
- Investigators
- Pan Li, PhD, Principal investigator, Changhai HospitalJian Na, MD, Study director, Putuo HospitalLiang Chen, MD, Study director, 904th Hospital of the Joint Logistics Support Force of the PLAWei Zhang, MD, Study director, Gongli HospitalYawei Yang, MD, Study director, Yueyang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409209
- Sponsor's protocol ID
- CPLi-2017
- Status last verified
- Jun 2022
- First submitted
- 3 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Plaque Length to Predict Cardiovascular Events
- ClinicalTrials.gov ID
- NCT05409209
- Acronym / sponsor ID
- CPLi-2017
- Conditions
- Coronary Artery Disease
- Keywords
- Carotid Artery Ultrasound, Carotid Plaque, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Putuo Hospital, Shanghai University of Traditional Chinese Medicine, 904th Hospital of the Joint Logistics Support Force of the PLA, Gongli Hospital, Yueyang Hospital, Shanghai University of Traditional Chinese medicine
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Jun 2022 (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.
This multicenter study involved 5 hospitals (Changhai Hospital; Yueyang Hospital of Shanghai University of Traditional Chinese Medicine; Gongli Hospital; Putuo Hospital of Shanghai University of Traditional Chinese Medicine; No. 904 Hospital of the PLA Joint Logistics Support Force Wuxi). The study enrolled 3000 patients for suspected CAD who referred to coronary angiography from January 2017 through December 2018.
Detailed description
Patients with coronary artery disease who were confirmed by coronary angiography were eligible for the study. Carotid ultrasonography was performed before coronary angiography, and carotid intima-media thickness (IMT), maximum thickness and length of all plaques were measured.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid plaque length | – | –Patients underwent carotid ultrasonography and first coronary angiography simultaneously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for first coronary angiography and underwent carotid ultrasonography simultaneously
Key inclusion criteria (1 listed)
- Patients≥18 years old, those who underwent carotid ultrasonography and first coronary angiography simultaneously.
Key exclusion criteria (1 listed)
- Patients with known coronary artery disease, previous coronary or carotid revascularization, missing carotid ultrasound or coronary angiography results.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
major cardiovascular event
Time frame: 3 years
A composite of cardiovascular death, myocardial infarction, and ischemic stroke
6 secondary outcomes
major vascular event
Time frame: 3 years
all-cause death
Time frame: 3 years
cardiovascular death
Time frame: 3 years
myocardial infarction
Time frame: 3 years
ischemic stroke
Time frame: 3 years
coronary artery revascularization
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Pan Li, PhD principal investigator
Changhai Hospital
Jian Na, MD study director
Putuo Hospital
Liang Chen, MD study director
904th Hospital of the Joint Logistics Support Force of the PLA
5 sites 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 Changhai Hospital at 5 sites 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 1 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: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
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 cardiovascular event (time frame: 3 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 Sep 2024.