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NCT Number: NCT07034157

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Percutaneous coronary intervention

Procedure

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

Cerebrovascular Intervention (CAS ）

Procedure

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

No Intervention / Observation

Other

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

Primary outcomes

  1. 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.

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

  5. Rate of cardiovascular and cerebrovascular events

    Time frame: 365±30 days

  6. Short-term complications

    Time frame: 90±7 days

  7. Long-term complications

    Time frame: 365±30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaochuan Huo, M.D.

CONTACT

[email protected]

+8613716292262

Xin Tong, M.D.

CONTACT

[email protected]

+8617810651085

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Acronym: ANGEL-UNIFY

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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