The Impact of Depression and/or Anxiety on PCI Patients

NCT ID: NCT03057691

Last Updated: 2018-11-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-11

Study Completion Date

2020-01-31

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome Depression Anxiety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaanxi Provincial People's Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Xi An City

UNKNOWN

Sponsor Role collaborator

Baoji Central Hospital

OTHER

Sponsor Role collaborator

General Hospital of Ningxia Medical University

OTHER

Sponsor Role collaborator

The People's Hospital of Ningxia

OTHER

Sponsor Role collaborator

Wuzhong City People's Hospital

UNKNOWN

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Xinjiang Provincial People's Hospital

UNKNOWN

Sponsor Role collaborator

the First Division Hospital of Xinjiang Production and Construction Corps

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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China

Central Contacts

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Juan Zhou, Professor

Role: CONTACT

0086-18191037350

Wenyuan Li

Role: CONTACT

0086-15191903966

Facility Contacts

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Juan Zhou, Professor

Role: primary

0086-18191037350

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.

Reference Type BACKGROUND
PMID: 26562328 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24566200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24237848 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18953212 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26144582 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20505844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26678632 (View on PubMed)

Nezafati MH, Vojdanparast M, Nezafati P. Antidepressants and cardiovascular adverse events: A narrative review. ARYA Atheroscler. 2015 Sep;11(5):295-304.

Reference Type BACKGROUND
PMID: 26715935 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26613707 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31492778 (View on PubMed)

Other Identifiers

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XJTU1AF-CRF-2016-004

Identifier Type: -

Identifier Source: org_study_id

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