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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

Tracking Information
First Submitted Date February 15, 2017
First Posted Date February 20, 2017
Last Update Posted Date November 16, 2018
Actual Study Start Date March 11, 2017
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2018)
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.
Original Primary Outcome Measures
 (submitted: February 15, 2017)
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 ]
Change History
Current Secondary Outcome Measures
 (submitted: November 14, 2018)
  • 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)
  • 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)
Original Secondary Outcome Measures
 (submitted: February 15, 2017)
  • all-cause mortality [ 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 ]
  • angina pectoris which needs 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 ]
  • heart failure [ 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 ]
  • change of blood pressure [ Time Frame: change from baseline at the 1st month, 3rd month, 6th month, 12th month, 18th month, 24month ]
  • change of fasting blood lipid [ Time Frame: change from baseline at the 1st month, 3rd month, 6th month, 12th month, 18th month, 24month ]
  • change of fasting blood glucose [ Time Frame: change from baseline at the 1st month, 3rd month, 6th month, 12th month, 18th month, 24month ]
  • change of echocardiogram [ Time Frame: change from baseline at the 1st month, 3rd month, 6th month, 12th month, 18th month, 24month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Impact of Depression and/or Anxiety on PCI Patients
Official Title The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention
Condition
  • Acute Coronary Syndrome
  • Depression
  • Anxiety
Intervention 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.
Study Groups/Cohorts
  • 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
    Intervention: Other: antidepressive and anti-anxiety therapy
  • Anxiety
    patients suffered from post-ACS anxiety who have undergone PCI
    Intervention: Other: antidepressive and anti-anxiety therapy
  • Depression with anxiety
    patients suffered from post-ACS depression with anxiety who have undergone PCI
    Intervention: Other: antidepressive and anti-anxiety therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: February 15, 2017)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03057691
Other Study ID Numbers XJTU1AF-CRF-2016-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor First Affiliated Hospital Xi'an Jiaotong University
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
Investigators
Study Director: Zuyi Yuan, Professor First Affiliated Hospital Xi'an Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date October 2018