The Impact of Depression and/or Anxiety on PCI Patients

Depression Clinical Trial

Official title:

The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057691
• Other study ID #: XJTU1AF-CRF-2016-004
• Status: Recruiting
• Start date: March 11, 2017
• Est. completion date: January 2020

Study information

• Verified date: October 2018
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Juan Zhou, Professor
• Phone: 0086-18191037350
• Email: 1306899042[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder
• Syndrome

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.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (11)

Lead Sponsor

Collaborator

First Affiliated Hospital Xi'an Jiaotong University

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

Country where clinical trial is conducted

China, 

References & Publications (9)

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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	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)	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