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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Coronary Heart Disease; Percutaneous Coronary Intervention
• Intervention / Treatment: Procedure: percutaneous coronary intervention

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 2600

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Major Adverse Events	major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.	36-month

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with All-cause Mortality	36-month
Number of Participants with Cardiovascular Mortality	36-month
Number of Participants with Myocardial Infarction	36-month
Number of Participants with In-Stent Thrombosis	36-month
Number of Participants with Target-Lesion Revascularization	36-month

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Shaoliang Chen, phd, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Behavioral Symptoms; Myocardial Ischemia; Behavior; Depression; Coronary Disease; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: 20180317

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No