The Impact of Depression and/or Anxiety on PCI Patients

NCT03057691 | Unknown

• 1 other identifier: XJTU1AF-CRF-2016-004
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Depression; Anxiety

Keywords

Acute Coronary Syndrome; Depression; Anxiety; Percutaneous Coronary Intervention; Major Adverse Cardiovascular Events

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events

  death, myocardial infarction, stroke, angina pectoris, revascularization.

  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 (2)

• Depression self-rating scales

  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

• Anxiety self-rating scales

  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

Study Arms (4)

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

antidepressive and anti-anxiety therapy 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; Depression; Depression with anxiety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention

You may qualify if:

• \. 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.

You may not qualify if:

• Severe heart failure, defined as left ventricular ejection fraction (LVEF)≤30% or New York Heart Association (NYHA) class≥III.
• Severe renal dysfunction, defined as creatinine clearance rate ≤30 ml/min.
• Cancer.
• Other severe mental illness including schizophrenia, severe dementia, substance abuse, etc.
• Bipolar disorder.
• Ongoing administration of antipsychotic, antidepressant, or antianxiety drugs.
• Serious risk of suicide.
• Severe, life-threatening medical condition (patients cannot participate in the study course).
• Pregnancy and lactation.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Shaanxi Provincial People's Hospital: collaborator
• The First Hospital of Xi An City: collaborator
• Baoji Central Hospital: collaborator
• General Hospital of Ningxia Medical University: collaborator
• The People's Hospital of Ningxia: collaborator
• Wuzhong City People's Hospital: collaborator
• LanZhou University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Xinjiang Provincial People's Hospital: collaborator
• the First Division Hospital of Xinjiang Production and Construction Corps: collaborator

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (10)

• 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.

  PMID: 26562328 BACKGROUND

• 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.

  PMID: 24566200 BACKGROUND

• 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.

  PMID: 24237848 BACKGROUND

• 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.

  PMID: 18953212 BACKGROUND

• 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.

  PMID: 26144582 BACKGROUND

• 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.

  PMID: 20505844 BACKGROUND

• 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.

  PMID: 26678632 BACKGROUND

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

  PMID: 26715935 BACKGROUND

• 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.

  PMID: 26613707 BACKGROUND

• 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.

  PMID: 31492778 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Depression; Anxiety Disorders

Interventions

Antidepressive Agents

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotropic Drugs; Central Nervous System Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Zuyi Yuan, Professor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Juan Zhou, Professor

CONTACT

0086-18191037350; 1306899042@qq.com

Wenyuan Li

CONTACT

0086-15191903966; lc3xlwy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 20, 2017
• Study Start: March 11, 2017
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: November 16, 2018

Record last verified: 2018-10

Locations

CN (1)