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

Active, not recruiting

• Conditions: Percutaneous Coronary Intervention; Coronary Heart Disease; Depression

• Registration Number: NCT03852082
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Study Start: 2019-08-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Major Adverse Events	12-month	major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Cardiovascular Mortality	12-month
Number of Participants with All-cause Mortality	12-month
Number of Participants with Myocardial Infarction	12-month
Number of Participants with Target-Lesion Revascularization	12-month
Number of Participants with In-Stent Thrombosis	12-month

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China