CClinicalTrials.gg
Status unknownNCT03057691Updated Nov 16, 2018

The Impact of Depression and/or Anxiety on PCI Patients

An observational study in Acute Coronary Syndrome, Depression and Anxiety, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-16.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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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Conditions studied

  • Acute Coronary Syndrome
  • Depression
  • Anxiety

Keywords

  • Acute Coronary Syndrome
  • Depression
  • Anxiety
  • Percutaneous Coronary Intervention
  • Major Adverse Cardiovascular Events
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 500 across 561 observational studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention

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.
  1. 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No

Groups and 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

    Other: antidepressive and anti-anxiety therapy

  • Anxiety

    patients suffered from post-ACS anxiety who have undergone PCI

    Other: antidepressive and anti-anxiety therapy

  • Depression with anxiety

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

    Other: antidepressive and anti-anxiety therapy

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.

06

What researchers measure

Primary outcomes

  1. Major Adverse Cardiovascular Events

    death, myocardial infarction, stroke, angina pectoris, 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

Secondary outcomes

  1. 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)

    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

  2. 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)

    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

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
    Recruiting
08

References and documents

Publications

  • Teply RM, Packard KA, White ND, Hilleman DE, DiNicolantonio JJ. Treatment of Depression in Patients with Concomitant Cardiac Disease. Prog Cardiovasc Dis. 2016 Mar-Apr;58(5):514-28. doi: 10.1016/j.pcad.2015.11.003. Epub 2015 Nov 10. PubMed 26562328 ↗
  • Lichtman JH, Froelicher ES, Blumenthal JA, Carney RM, Doering LV, Frasure-Smith N, Freedland KE, Jaffe AS, Leifheit-Limson EC, Sheps DS, Vaccarino V, Wulsin L; American Heart Association Statistics Committee of the Council on Epidemiology and Prevention and the Council on Cardiovascular and Stroke Nursing. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014 Mar 25;129(12):1350-69. doi: 10.1161/CIR.0000000000000019. Epub 2014 Feb 24. PubMed 24566200 ↗
  • Oldroyd JC, Cyril S, Wijayatilaka BS, O'Neil A, McKenzie DP, Zavarsek S, Sanderson K, Hare DL, Fisher AJ, Forbes AB, Barr Taylor C, Clarke DM, Meredith IT, Oldenburg B. Evaluating the impact of depression, anxiety & autonomic function on health related quality of life, vocational functioning and health care utilisation in acute coronary syndrome patients: the ADVENT study protocol. BMC Cardiovasc Disord. 2013 Nov 17;13:103. doi: 10.1186/1471-2261-13-103. PubMed 24237848 ↗
  • Regan KL. Depression treatment with selective serotonin reuptake inhibitors for the postacute coronary syndrome population: a literature review. J Cardiovasc Nurs. 2008 Nov-Dec;23(6):489-96. doi: 10.1097/01.JCN.0000338929.89210.af. PubMed 18953212 ↗
  • Ossola P, Paglia F, Pelosi A, De Panfilis C, Conte G, Tonna M, Ardissino D, Marchesi C. Risk factors for incident depression in patients at first acute coronary syndrome. Psychiatry Res. 2015 Aug 30;228(3):448-53. doi: 10.1016/j.psychres.2015.05.063. Epub 2015 Jun 27. PubMed 26144582 ↗
  • Huffman JC, Celano CM, Januzzi JL. The relationship between depression, anxiety, and cardiovascular outcomes in patients with acute coronary syndromes. Neuropsychiatr Dis Treat. 2010 May 6;6:123-36. doi: 10.2147/ndt.s6880. PubMed 20505844 ↗
  • Celano CM, Millstein RA, Bedoya CA, Healy BC, Roest AM, Huffman JC. Association between anxiety and mortality in patients with coronary artery disease: A meta-analysis. Am Heart J. 2015 Dec;170(6):1105-15. doi: 10.1016/j.ahj.2015.09.013. Epub 2015 Sep 21. PubMed 26678632 ↗
  • Nezafati MH, Vojdanparast M, Nezafati P. Antidepressants and cardiovascular adverse events: A narrative review. ARYA Atheroscler. 2015 Sep;11(5):295-304. PubMed 26715935 ↗
  • Marke V, Bennett P. Predicting negative emotional states following first onset acute coronary syndrome. J Health Psychol. 2017 May;22(6):765-775. doi: 10.1177/1359105315614996. Epub 2015 Nov 26. PubMed 26613707 ↗
  • Xiao Y, Li W, Zhou J, Zheng J, Cai X, Guo M, Hao X, Zhang Z, Liu Y, Yuan Z. Impact of depression and/or anxiety on patients with percutaneous coronary interventions after acute coronary syndrome: a protocol for a real-world prospective cohort study. BMJ Open. 2019 Sep 5;9(9):e027964. doi: 10.1136/bmjopen-2018-027964. PubMed 31492778 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03057691
Lead 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
Responsible party
Sponsor
First posted
Feb 20, 2017
Start date
Mar 11, 2017
Primary completion
Dec 2019 (estimated)
Completion
Jan 2020 (estimated)
Last update
Nov 16, 2018

Study contacts

Juan Zhou, Professor
Contact
1306899042@qq.com
0086-18191037350
Wenyuan Li
Contact
lc3xlwy@126.com
0086-15191903966
Zuyi Yuan, Professor
study director · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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