The Impact of Depression and/or Anxiety on PCI Patients

• Conditions: Depression; Anxiety; Acute Coronary Syndrome
• Interventions: Other: antidepressive and anti-anxiety therapy

• Registration Number: NCT03057691
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The purpose of this study is to evaluate how depression and/or anxiety could effect the prognosis of the patients post-ACS after PCI.

Detailed Description

This trial is a prospective, multi-centric, real-world clinical study. About 5,000 patients with ACS post-PCI will be recruited according to the resource available of each participating center to represent real-world setting. Patients enrolled in the project will accept two-years' follow-up and will be assessed on mortality, cardiovascular events, and severity of depressive or anxiety symptoms using self-rating scales continuously during the trial, in which their treatment for anxiety or depression will also be documented.

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Study Start: 2017-03-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-11-14
• Last Update Posted: 2018-11-16
• Primary Completion: 2019-12
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anxiety	antidepressive and anti-anxiety therapy	patients suffered from post-ACS anxiety who have undergone PCI
Depression	antidepressive and anti-anxiety therapy	patients suffered from post-ACS depression who have undergone PCI
Depression with anxiety	antidepressive and anti-anxiety therapy	patients suffered from post-ACS depression with anxiety who have undergone PCI

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	From date of first visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	death, myocardial infarction, stroke, angina pectoris, revascularization.

Secondary Outcome Measures

Name	Time	Method
Depression self-rating scales	From date of first visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	results of depression scales assessed by The Patient Health Questionnaire-2 (PHQ-2, scores ≤2 non, \>2 continue PHQ-9) or PHQ-9 (scores ≤4 non, 5\~9 mild, 10\~19 mediate, ≥ 20 severe)
Anxiety self-rating scales	From date of first visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	results of anxiety scales assessed by Generalized Anxiety Disorder 2-item(GAD-2, scores ≤2 non, \>2 continue GAD-7) or GAD-7 (scores ≤4 non, 5\~9 mild, 10\~14 mediate, ≥15 severe)

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China