The Impact of Depression and/or Anxiety on PCI Patients
NCT ID: NCT03057691
Last Updated: 2018-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
5000 participants
OBSERVATIONAL
2017-03-11
2020-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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No depression/anxiety
patients suffered from ACS who have undergone PCI without depression or anxiety
No interventions assigned to this group
Depression
patients suffered from post-ACS depression who have undergone PCI
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Shaanxi Provincial People's Hospital
OTHER
The First Hospital of Xi An City
UNKNOWN
Baoji Central Hospital
OTHER
General Hospital of Ningxia Medical University
OTHER
The People's Hospital of Ningxia
OTHER
Wuzhong City People's Hospital
UNKNOWN
LanZhou University
OTHER
First Affiliated Hospital of Xinjiang Medical University
OTHER
Xinjiang Provincial People's Hospital
UNKNOWN
the First Division Hospital of Xinjiang Production and Construction Corps
UNKNOWN
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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Zuyi Yuan, Professor
Role: STUDY_DIRECTOR
First Affiliated Hospital Xi'an Jiaotong University
Locations
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First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Nezafati MH, Vojdanparast M, Nezafati P. Antidepressants and cardiovascular adverse events: A narrative review. ARYA Atheroscler. 2015 Sep;11(5):295-304.
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.
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.
Other Identifiers
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XJTU1AF-CRF-2016-004
Identifier Type: -
Identifier Source: org_study_id
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