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

NCT ID: NCT03852082

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-28
• Study Completion Date: 2025-12-30

Brief Summary

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.

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.

Conditions

Coronary Heart Disease; Percutaneous Coronary Intervention; Depression

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

percutaneous coronary intervention

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shaoliang Chen, MD

Vice President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaoliang Chen, phd

Role: STUDY_CHAIR

Nanjing First Hospital, Nanjing Medical University

Locations

Nanjing First Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

20180317

Identifier Type: -

Identifier Source: org_study_id