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

NCT03852082 | Active Not Recruiting DMC

• 1 other identifier: 20180317
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Percutaneous Coronary Intervention; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Interventions

percutaneous coronary intervention PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

MeSH Terms

Conditions

Coronary Disease; Depression

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Shaoliang Chen, phd

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: August 28, 2019
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)