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

Depression Clinical Trial

— PCICODE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03852082
• Other study ID #: 20180317
• Status: Active, not recruiting
• Start date: August 28, 2019
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2600
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Depression
• Depressive Disorder
• Heart Diseases
• Myocardial Ischemia
• Percutaneous Coronary Intervention

Intervention

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

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Major Adverse Events	major adverse events were including all-cause mortality, myocardial infarction, in-stent thrombosis and target vessel revascularization.	12-month
Secondary	Number of Participants with All-cause Mortality		12-month
Secondary	Number of Participants with Cardiovascular Mortality		12-month
Secondary	Number of Participants with Myocardial Infarction		12-month
Secondary	Number of Participants with In-Stent Thrombosis		12-month
Secondary	Number of Participants with Target-Lesion Revascularization		12-month