The Impact of Depression and/or Anxiety on PCI Patients

Xi'an Jiaotong University

Status: Unknown

Conditions: Acute Coronary Syndrome; Depression; Anxiety

Treatments: Other: antidepressive and anti-anxiety therapy

Study type: Observational

Funder types: Other

Identifiers

NCT03057691

XJTU1AF-CRF-2016-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

2. Good recovery from PCI. 4. Volunteer for the study and sign the informed consent. Exclusion Criteria

3. Severe heart failure, defined as left ventricular ejection fraction (LVEF)≤30% or New York Heart Association (NYHA) class≥III.

4. Severe renal dysfunction, defined as creatinine clearance rate ≤30 ml/min.

5. Cancer.

6. Other severe mental illness including schizophrenia, severe dementia, substance abuse, etc.

7. Bipolar disorder.

8. Ongoing administration of antipsychotic, antidepressant, or antianxiety drugs.

9. Serious risk of suicide.

10. Severe, life-threatening medical condition (patients cannot participate in the study course).

11. Pregnancy and lactation.

Trial design

5,000 participants in 4 patient groups

No depression/anxiety

Description:

patients suffered from ACS who have undergone PCI without depression or anxiety

Depression

Description:

patients suffered from post-ACS depression who have undergone PCI

Treatment:

Other: antidepressive and anti-anxiety therapy

Anxiety

Description:

patients suffered from post-ACS anxiety who have undergone PCI

Treatment:

Other: antidepressive and anti-anxiety therapy

Depression with anxiety

Description:

patients suffered from post-ACS depression with anxiety who have undergone PCI

Treatment:

Other: antidepressive and anti-anxiety therapy