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The Impact of Depression and/or Anxiety on PCI Patients

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ClinicalTrials.gov Identifier: NCT03057691
Recruitment Status : Unknown
Verified October 2018 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Recruiting
First Posted : February 20, 2017
Last Update Posted : November 16, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Depression Anxiety Other: antidepressive and anti-anxiety therapy

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions
Actual Study Start Date : March 11, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
No depression/anxiety
patients suffered from ACS who have undergone PCI without depression or anxiety
Depression
patients suffered from post-ACS depression who have undergone PCI
Other: antidepressive 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.

Anxiety
patients suffered from post-ACS anxiety who have undergone PCI
Other: antidepressive 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.

Depression with anxiety
patients suffered from post-ACS depression with anxiety who have undergone PCI
Other: antidepressive 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.




Primary Outcome Measures :
  1. Major Adverse Cardiovascular Events [ 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 ]
    death, myocardial infarction, stroke, angina pectoris, revascularization.


Secondary Outcome Measures :
  1. Depression self-rating scales [ 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 ]
    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)

  2. Anxiety self-rating scales [ 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 ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057691


Contacts
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Contact: Juan Zhou, Professor 0086-18191037350 1306899042@qq.com
Contact: Wenyuan Li 0086-15191903966 lc3xlwy@126.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Juan Zhou, Professor    0086-18191037350    1306899042@qq.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
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
Investigators
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Study Director: Zuyi Yuan, Professor First Affiliated Hospital Xi'an Jiaotong University
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03057691    
Other Study ID Numbers: XJTU1AF-CRF-2016-004
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: October 2018
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Acute Coronary Syndrome
Depression
Anxiety
Percutaneous Coronary Intervention
Major Adverse Cardiovascular Events
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Depression
Depressive Disorder
Anxiety Disorders
Disease
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Antidepressive Agents
Psychotropic Drugs