A Real-World Study on Ultrasound-Based Screening and Integrated Therapeutic Strategies for Patients With Concomitant Coronary and Cervicocephalic Artery Stenosis

NCT07034157 | Recruiting DMC

• 1 other identifier: KS2025006
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Coronary Artery Disease; Carotid Artery Stenosis; Cerebrovascular Disorders

Keywords

Coronary Artery Disease; Carotid Artery Stenosis; Doppler Ultrasound; Combined Vascular Intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline (prior to or during initial hospitalization)

Secondary Outcomes (7)

• mRS score

  7±1 days or the day discharged

• mRS Score

  90±7 days

• mRS Score

  365±30 days

• Rate of cardiovascular and cerebrovascular events

  90±7 days

• Rate of cardiovascular and cerebrovascular events

  365±30 days

Study Arms (3)

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.

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.

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.

Other: No Intervention / Observation

Interventions

Percutaneous Coronary Intervention PROCEDURE

Coronary stenting performed as part of routine care for patients with coronary artery stenosis.

Group 1: PCI + Carotid Revascularization; Group 2: PCI + Observation of Carotid Stenosis

Cerebrovascular Intervention (CAS ） PROCEDURE

Patients with intervention-indicated head and neck artery stenosis will receive carotid artery stenting based on clinical evaluation.

Group 1: PCI + Carotid Revascularization

No Intervention / Observation OTHER

Clinical observation or standard follow-up in patients without significant disease

Group 2: PCI + Observation of Carotid Stenosis; Group 3: Observation Only (No PCI + No CAS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Age ≥18 years;
• Patients with coronary artery disease scheduled to undergo elective percutaneous coronary intervention (PCI) on the following day.

You may not qualify if:

• The expected survival is less than 1 years;
• Simultaneously merge other serious diseases;

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Carotid Stenosis; Cerebrovascular Disorders

Interventions

Percutaneous Coronary Intervention; Observation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Carotid Artery Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Methods; Investigative Techniques

Central Study Contacts

Xiaochuan Huo, M.D.

CONTACT

+8613716292262; huoxiaochuan@126.com

Xin Tong, M.D.

CONTACT

+8617810651085; Tomice123@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: June 24, 2025
• Study Start: June 9, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)