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NCT Number: NCT03852082

Predictors and Clinical Outcomes of Patients With Coronary Heart Disease Co-morbid Depression Post Percutaneous Coronary Intervention

A prospective, multicenter, registered cohort study to observe the incidence of 1-year major adverse cardiac events in patients with coronary heart disease co-morbid depression treated with percutaneous coronary intervention and to clarify the predictors of 1-year major adverse cardiac events post PCI among these patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

Coronary heart disease (CHD) is a clinical relevant psychosomatic issue. Treatment strategies include percutaneous coronary intervention (PCI), guidelines medication (GDMT) and coronary artery bypass grafting (CABG) were clinical proven to be effective to realize myocardial revascularization post CHD. Previous studies revealed that diagnosed depressed CHD patients have 3.6 times higher risk of major adverse events (MACE) post percutaneous coronary intervention than nondepressed. However, a reliable explanation of how depression impact clinical outcomes of CHD patients post PCI is lacking. The objective of this study is to observe the incidence of major adverse cardiovascular events in patients with coronary heart disease co-morbid with depression post PCI, and to explore a prognostic model of clinical outcomes based on physiological, interventional, socio-economic and psychological factors among these patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures;
  • Men and women 18 years or older;
  • Diagnosed CHD needed to and can be treated with PCI according to the guidelines of ACC/AHA;
  • Willingness to participate in the follow-up study for at least 1 year.

Exclusion criteria

  • Inability to provide written informed consent;
  • Diagnosed mental illness or medical history (including schizophrenia, bipolar disorder, severe dementia or Lifetime alcohol or substance abuse);
  • Tendency of suicide;
  • Pregnant or lactating women;
  • Any physical or intellectual inability or disability that may affect completion of self-assessment tools, study protocol and follow-up requirements;
  • Any other reasons that investigators based on professional judgments that would place the patient at increased risk.
  • Patient with STEMI within 24-hour from the onset of chest pain to admission.

Treatment and study plan

Percutaneous coronary intervention

Procedure

Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention.

Primary outcomes

  1. Number of Participants with Major Adverse Events

    Time frame: 36-month

    major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.

Secondary outcomes

  1. Number of Participants with All-cause Mortality

    Time frame: 36-month

  2. Number of Participants with Cardiovascular Mortality

    Time frame: 36-month

  3. Number of Participants with Myocardial Infarction

    Time frame: 36-month

  4. Number of Participants with In-Stent Thrombosis

    Time frame: 36-month

  5. Number of Participants with Target-Lesion Revascularization

    Time frame: 36-month

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Acronym: PCICODE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2019
Registry last updated
Apr 13, 2026

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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