Clinical Outcomes of Patients With Coronary Artery Disease

NCT06216847 | Recruiting DMC

• 1 other identifier: COCAD V1.0
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary heart disease (CHD) stands as a foremost contributor to global mortality, characterized by complex pathogenesis that renders conventional "one-size-fits-all" preventive strategies inefficient. Therefore, the investigators designed a prospective, multi-center cohort study among patients hospitalized due to either confirmed or suspected CHD, which aimed to establish a holographic data set for the diagnosis and treatment of CHD and explore the impact of critical therapeutic strategies in the real world on the clinical outcomes of CHD patients, providing evidence to optimize the management pathway.

Conditions

Coronary Heart Disease (CHD)

Outcome Measures

Primary Outcomes (1)

• Ischemic events

  defined as the composite of cardiac death, myocardial infarction, or stroke

  During 12-month follow up

Secondary Outcomes (5)

• Major adverse cardiovascular and cerebrovascular events (MACCE)

  During 1/2/3/4/5-year follow up

• Cardiac death

  During 1/2/3/4/5-year follow up

• Stent thrombosis

  During 1/2/3/4/5-year follow up

• Major bleeding events

  During 1/2/3/4/5-year follow up

• Clinical relevant bleeding events

  During 1/2/3/4/5-year follow up

Eligibility Criteria

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

Study Population

patients hospitalized due to either confirmed or suspected CHD

You may qualify if:

• Age ≥ 18 years old
• Hospitalization due to either confirmed or suspected CHD combined with one of the following features: previous PCI or CABG; previous myocardial infarction; previous coronary angiography revealing ≥ 50% stenosis in major coronary vessels; presentation with chest pain and pre-test probability of CHD \> 65%; laboratory tests revealing objective evidence of myocardial ischemia; coronary CT angiography (CTA) showed ≥ 30% stenosis in major coronary vessels
• Subjects undergoing at least one coronary imaging and one functional examination. Imaging examinations include coronary CTA, intravascular ultrasound (IVUS), or optical coherence tomography (OCT). Functional examination include fraction flow reservation (FFR), CT-FFR or quantitative flow ratio (QFR).
• Written informed consent provided.

You may not qualify if:

• History of mental illness, drug or alcohol abuse, or being unable to cooperate with follow-up visits for any reason;
• Life expectancy \<1 year
• Pregnant or plan to be pregnant within 1 year
• Subjects participating in any other clinical trial

Sponsors & Collaborators

• Shenyang Northern Hospital: lead

Study Sites (1)

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

RECRUITING

Related Publications (17)

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MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yaling Han, MD

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Li, MD

CONTACT

+86-24-28897309; doctorliyi@126.com

Yaling Han, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: February 21, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2030
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)