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

ConditionsCoronary Artery DiseaseCarotid Artery StenosisCerebrovascular Disorders
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Anzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years;

Patients with coronary artery disease scheduled to undergo elective percutaneous coronary intervention (PCI) on the following day.

Disqualifiers

The expected survival is less than 1 years;

Simultaneously merge other serious diseases;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Percutaneous Coronary Intervention

    Procedure/Surgery

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

  • Cerebrovascular Intervention (CAS ）

    Procedure/Surgery

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

  • No Intervention / Observation

    Other intervention

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

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Group 1: PCI + Carotid Revascularization2 interventions
Group B: Group 2: PCI + Observation of Carotid Stenosis2 interventions
Group C: Group 3: Observation Only (No PCI + No CAS)1 intervention

Trial outcomes

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.

Time frame
At baseline (prior to or during initial hospitalization)

Secondary outcomes

1

mRS score

Time frame
7±1 days or the day discharged
2

mRS Score

Time frame
90±7 days
3

mRS Score

Time frame
365±30 days
4

Rate of cardiovascular and cerebrovascular events

Time frame
90±7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Anzhen Hospital

Lead sponsor

Source ClinicalTrials.gov
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