The Impact of Depression and/or Anxiety on PCI Patients

First Affiliated Hospital Xi'an Jiaotong University5,000 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

5,000

Conditions

Acute Coronary Syndrome Depression Anxiety

Interventions

antidepressive and anti-anxiety therapyOTHER

These therapies include antidepressants, antianxiety drugs and psychotherapy. Subjects choose the therapy follow their own will. All of the above-mentioned therapies are identified by experienced psychiatrists in the same center. The treatment information will be recorded in each visit. The study is considered non-interventional, and no antidepressive or anti-anxiety therapies are mandated.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria 1\. Aged \> 18 years old 2. Patients with a diagnosis of ACS including acute myocardial infarction (MI) and unstable angina (UA). Acute MI diagnosis must be met with at least two of these following criteria: typical chest pain, abnormal elevation of cardiac biomarkers, and electrocardiographic changes consist with MI. The diagnosis of UA includes new onset angina within 1 month, crescendo angina, resting angina, infarction angina, and variant angina. 3\. Good recovery from PCI. 4. Volunteer for the study and sign the informed consent. Exclusion Criteria 1. Severe heart failure, defined as left ventricular ejection fraction (LVEF)≤30% or New York Heart Association (NYHA) class≥III. 2. Severe renal dysfunction, defined as creatinine clearance rate ≤30 ml/min. 3. Cancer. 4. Other severe mental illness including schizophrenia, severe dementia, substance abuse, etc. 5. Bipolar disorder. 6. Ongoing administration of antipsychotic, antidepressant, or antianxiety drugs. 7. Serious risk of suicide. 8. Severe, life-threatening medical condition (patients cannot participate in the study course). 9. Pregnancy and lactation.

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Outcomes

Primary Outcomes

Major Adverse Cardiovascular Events

death, myocardial infarction, stroke, angina pectoris, revascularization.

Time frame: 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

Secondary Outcomes

Depression self-rating scales

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)

Time frame: 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

Anxiety self-rating scales

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)

Time frame: 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

Central Contacts

Juan Zhou, Professor

CONTACT

0086-18191037350 1306899042@qq.com

Wenyuan Li

CONTACT

0086-15191903966 lc3xlwy@126.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.