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NCT Number: NCT06216847

Clinical Outcomes of Patients With Coronary Artery Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110016, China

Location status: Recruiting

Location contact

About this study

Coronary heart disease (CHD) stands as a foremost contributor to global mortality. Despite the increasing investment in the prevention of risk factors and the popularization of percutaneous coronary intervention (PCI), the age-standardized incidence and mortality of CHD continue to increase. CHD is characterized by complex pathogenesis, rendering conventional "one-size-fits-all" preventive strategies inefficient.

Currently, there is a need to address two critical challenges. The first centers on early detection, precise risk stratification, and personalized intervention strategies for high-risk CHD patients, with a focus on the exploration of inflammation-driven risks, lesion-based risk stratification, and tailored anti-thrombotic therapies. The second challenge lies in the transformation of clinical risk assessment and decision-making processes into a precise level through the utilization of big data mining techniques.

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Other conditions deemed unsuitable for inclusion by the investigator

Treatment and study plan

Primary outcomes

  1. Ischemic events

    Time frame: During 12-month follow up

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

Secondary outcomes

  1. Major adverse cardiovascular and cerebrovascular events (MACCE)

    Time frame: During 1/2/3/4/5-year follow up

    defined as a composite of all-cause death, myocardial infarction, ischemic stroke and target-vessel revascularization

  2. Cardiac death

    Time frame: During 1/2/3/4/5-year follow up

  3. Stent thrombosis

    Time frame: During 1/2/3/4/5-year follow up

  4. Major bleeding events

    Time frame: During 1/2/3/4/5-year follow up

    defined as BARC types 3 or 5 bleeding events

  5. Clinical relevant bleeding events

    Time frame: During 1/2/3/4/5-year follow up

    defined as BARC type 2-5 bleeding events

Study contacts

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

Yaling Han, MD

CONTACT

Yi Li, MD

CONTACT

[email protected]

+86-24-28897309

Sponsors and collaborators

Lead sponsor

Shenyang Northern Hospital

Other

Registry information

Official study title

Clinical Outcomes of Patients With Coronary Artery Disease Cohort Study

Acronym: COCAD

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Jan 22, 2024
Registry last updated
Sep 10, 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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