Acute Coronary Syndrome, Anxiety, Depression
Conditions
Keywords
Acute Coronary Syndrome, Depression, Anxiety, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events
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.
Interventions
OTHERantidepressive and anti-anxiety therapy
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.
Sponsors
Shaanxi Provincial People's Hospital
The First Hospital of Xi An City
Baoji Central Hospital
General Hospital of Ningxia Medical University
The People's Hospital of Ningxia
Wuzhong City People's Hospital
LanZhou University
First Affiliated Hospital of Xinjiang Medical University
Xinjiang Provincial People's Hospital
the First Division Hospital of Xinjiang Production and Construction Corps
First Affiliated Hospital Xi'an Jiaotong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Contacts
Primary ContactJuan Zhou, Professor
Backup ContactWenyuan Li
Outcome results
None listed