Coronary Artery DiseaseANGEL-UNIFYNCT07034157
A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis
An observational study of Coronary Artery Disease and Carotid Artery Stenosis, run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
This prospective observational cohort study aims to investigate the prevalence and clinical significance of head and neck arterial stenosis in patients with coronary artery disease (CAD) undergoing or scheduled for percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Carotid Artery Stenosis, Cerebrovascular Disorders
- What is being tested?
- Percutaneous Coronary Intervention and Cerebrovascular Intervention (CAS ）
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2025to 30 Dec 2026
- How long will I take part?
- 1 Year
- 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: Adult patients (aged ≥18 years) diagnosed with coronary artery stenosis who are scheduled for or have recently undergone percutaneous coronary intervention (PCI), and who will undergo ultrasound screening for concomitant head and neck arterial stenosis. Participants will be enrolled from a tertiary care hospital in China as part of a prospective observational cohort.
Who may be able to join
- Age ≥18 years;
- Patients with coronary artery disease scheduled to undergo elective percutaneous coronary intervention (PCI) on the following day.
Who cannot join
- The expected survival is less than 1 years;
- Simultaneously merge other serious diseases;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing
Xin Tong, +86 1781065108, Tomice123@foxmail.com
About this study
This prospective observational cohort study aims to investigate the prevalence and clinical significance of head and neck arterial stenosis in patients with coronary artery disease (CAD) undergoing or scheduled for percutaneous coronary intervention (PCI). Using Doppler ultrasound as the primary screening tool, the study will assess the degree of stenosis and evaluate the impact of different combined treatment strategies on patient outcomes. The research will provide real-world evidence to optimize integrated care approaches for patients with comorbid cardiovascular and cerebrovascular diseases.
- Being tested
- Percutaneous Coronary Intervention, Cerebrovascular Intervention (CAS ）, No Intervention / Observation
- Keywords
- Coronary Artery Disease, Carotid Artery Stenosis, Doppler Ultrasound, Combined Vascular Intervention
- Medical subject headings
- Coronary Artery Disease, Carotid Stenosis, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterventionProcedure or surgery
Coronary stenting performed as part of routine care for patients with coronary artery stenosis.
Cerebrovascular Intervention (CAS ）Procedure or surgery
Patients with intervention-indicated head and neck artery stenosis will receive carotid artery stenting based on clinical evaluation.
No Intervention / ObservationOther
Clinical observation or standard follow-up in patients without significant disease
| Study group | Role | What they receive |
|---|---|---|
| Group 1: PCI + Carotid Revascularization | Patients diagnosed with both coronary artery disease and significant carotid artery stenosis requiring intervention, who received both PCI and carotid revascularization. Receives: Procedure: Percutaneous Coronary Intervention; Procedure: Cerebrovascular Intervention (CAS ） | |
| Group 2: PCI + Observation of Carotid Stenosis | Patients who underwent PCI for coronary artery disease, with no carotid stenosis or with carotid stenosis not requiring or not receiving interventional treatment. Receives: Procedure: Percutaneous Coronary Intervention; Other: No Intervention / Observation | |
| Group 3: Observation Only (No PCI + No CAS) | Patients who did not undergo PCI and either had no carotid artery stenosis or were managed medically for carotid stenosis without any revascularization. Receives: Other: No Intervention / Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Head and Neck Artery Stenosis in Patients with Coronary Artery Disease
The proportion of patients with coronary artery disease who are found to have head and neck artery (e.g., carotid or vertebral artery) stenosis, as determined by duplex ultrasound or other imaging modalities.
Measured: At baseline (prior to or during initial hospitalization)
Secondary outcomes (7)
mRS score
Measured: 7±1 days or the day discharged
mRS Score
Measured: 90±7 days
mRS Score
Measured: 365±30 days
Rate of cardiovascular and cerebrovascular events
Measured: 90±7 days
Rate of cardiovascular and cerebrovascular events
Measured: 365±30 days
Short-term complications
Measured: 90±7 days
Long-term complications
Measured: 365±30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start9 Jun 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Dec 2026 (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.
- 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 (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaochuan Huo, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034157
- Sponsor's protocol ID
- KS2025006
- Acronym
- ANGEL-UNIFY
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis
- ClinicalTrials.gov ID
- NCT07034157
- Acronym / sponsor ID
- ANGEL-UNIFY / KS2025006
- Keywords
- Coronary Artery Disease, Carotid Artery Stenosis, Doppler Ultrasound, Combined Vascular Intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jun 2025 (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 prospective observational cohort study aims to investigate the prevalence and clinical significance of head and neck arterial stenosis in patients with coronary artery disease (CAD) undergoing or scheduled for percutaneous coronary intervention (PCI). Using Doppler ultrasound as the primary screening tool, the study will assess the degree of stenosis and evaluate the impact of different combined treatment strategies on patient outcomes. The research will provide real-world evidence to optimize integrated care approaches for patients with comorbid cardiovascular and cerebrovascular diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: PCI + Carotid Revascularization | – | Procedure: Percutaneous Coronary Intervention, Procedure: Cerebrovascular Intervention (CAS ）Patients diagnosed with both coronary artery disease and significant carotid artery stenosis requiring intervention, who received both PCI and carotid revascularization. |
| Group 2: PCI + Observation of Carotid Stenosis | – | Procedure: Percutaneous Coronary Intervention, Other: No Intervention / ObservationPatients who underwent PCI for coronary artery disease, with no carotid stenosis or with carotid stenosis not requiring or not receiving interventional treatment. |
| Group 3: Observation Only (No PCI + No CAS) | – | Other: No Intervention / ObservationPatients who did not undergo PCI and either had no carotid artery stenosis or were managed medically for carotid stenosis without any revascularization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (aged ≥18 years) diagnosed with coronary artery stenosis who are scheduled for or have recently undergone percutaneous coronary intervention (PCI), and who will undergo ultrasound screening for concomitant head and neck arterial stenosis. Participants will be enrolled from a tertiary care hospital in China as part of a prospective observational cohort.
Key inclusion criteria (2 listed)
- Age ≥18 years;
- Patients with coronary artery disease scheduled to undergo elective percutaneous coronary intervention (PCI) on the following day.
Key exclusion criteria (2 listed)
- The expected survival is less than 1 years;
- Simultaneously merge other serious diseases;
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 |
|---|---|---|
| Percutaneous Coronary InterventionCoronary stenting performed as part of routine care for patients with coronary artery stenosis. | Procedure or surgery | Group 1: PCI + Carotid Revascularization, Group 2: PCI + Observation of Carotid Stenosis |
| Cerebrovascular Intervention (CAS ）Patients with intervention-indicated head and neck artery stenosis will receive carotid artery stenting based on clinical evaluation. | Procedure or surgery | Group 1: PCI + Carotid Revascularization |
| No Intervention / ObservationClinical observation or standard follow-up in patients without significant disease | Other | Group 2: PCI + Observation of Carotid Stenosis, Group 3: Observation Only (No PCI + No CAS) |
Primary outcome
Prevalence of Head and Neck Artery Stenosis in Patients with Coronary Artery Disease
Time frame: At baseline (prior to or during initial hospitalization)
The proportion of patients with coronary artery disease who are found to have head and neck artery (e.g., carotid or vertebral artery) stenosis, as determined by duplex ultrasound or other imaging modalities.
7 secondary outcomes
mRS score
Time frame: 7±1 days or the day discharged
mRS Score
Time frame: 90±7 days
mRS Score
Time frame: 365±30 days
Rate of cardiovascular and cerebrovascular events
Time frame: 90±7 days
Rate of cardiovascular and cerebrovascular events
Time frame: 365±30 days
Short-term complications
Time frame: 90±7 days
Long-term complications
Time frame: 365±30 days
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 24 Jun 2025.
- 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.
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 Carotid Artery Stenosis, run by Beijing Anzhen 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 2 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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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?
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?
Contact Xiaochuan Huo, M.D. (+8613716292262, huoxiaochuan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Head and Neck Artery Stenosis in Patients with Coronary Artery Disease (time frame: At baseline (prior to or during initial hospitalization)). 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 24 Jun 2025.