The Impact of Depression and/or Anxiety on PCI Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions

Conditions
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Acute Coronary Syndrome, Depression, Anxiety

Intervention / Treatment
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* Other: antidepressive and anti-anxiety therapy


Participation Criteria
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Eligibility Criteria
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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 Severe heart failure, defined as left ventricular ejection fraction (LVEF)≤30% or New York Heart Association (NYHA) class≥III. Severe renal dysfunction, defined as creatinine clearance rate ≤30 ml/min. Cancer. Other severe mental illness including schizophrenia, severe dementia, substance abuse, etc. Bipolar disorder. Ongoing administration of antipsychotic, antidepressant, or antianxiety drugs. Serious risk of suicide. Severe, life-threatening medical condition (patients cannot participate in the study course). Pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No depression/anxiety<br>patients suffered from ACS who have undergone PCI without depression or anxiety | |
| Depression<br>patients suffered from post-ACS depression who have undergone PCI | Other: antidepressive and anti-anxiety therapy<br>* 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.<br>|
| Anxiety<br>patients suffered from post-ACS anxiety who have undergone PCI | Other: antidepressive and anti-anxiety therapy<br>* 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.<br>|
| Depression with anxiety<br>patients suffered from post-ACS depression with anxiety who have undergone PCI | Other: antidepressive and anti-anxiety therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiovascular Events | death, myocardial infarction, stroke, angina pectoris, revascularization. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Coronary Syndrome, Depression, Anxiety, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events