The Impact of Depression and/or Anxiety on PCI Patients

• ClinicalTrials.gov Identifier: NCT03057691
• Recruitment Status: Unknown
• First Posted: February 20, 2017
• Last Update Posted: November 16, 2018
• 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
• Information provided by (Responsible Party): First Affiliated Hospital Xi'an Jiaotong University

Study Description

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.

Condition or disease	Intervention/treatment
Acute Coronary Syndrome; Depression; Anxiety	Other: antidepressive and anti-anxiety therapy

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 5000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions
• Actual Study Start Date: March 11, 2017
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: January 2020

Groups and Cohorts

Group/Cohort	Intervention/treatment
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; 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	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.
Depression with anxiety; patients suffered from post-ACS depression with anxiety who have undergone PCI	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.

Outcome Measures

Primary Outcome Measures :

1. Major Adverse Cardiovascular Events [ 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 ]
   death, myocardial infarction, stroke, angina pectoris, revascularization.

Secondary Outcome Measures :

1. Depression self-rating scales [ 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 ]
   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)
2. Anxiety self-rating scales [ 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 ]
   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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention

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.

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.

Contacts and Locations

Contacts

Contact: Juan Zhou, Professor; 0086-18191037350; 1306899042@qq.com

Contact: Wenyuan Li; 0086-15191903966; lc3xlwy@126.com

Locations

China, Shaanxi

First Affiliated Hospital of Xi'an Jiaotong University; Recruiting

Xi'an, Shaanxi, China, 710061

Contact: Juan Zhou, Professor 0086-18191037350 1306899042@qq.com

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

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

Investigators

• Study Director: Zuyi Yuan, Professor; First Affiliated Hospital Xi'an Jiaotong University

More Information

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. Review.

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.

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. Review.

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.

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.

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

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
• ClinicalTrials.gov Identifier: NCT03057691
• Other Study ID Numbers: XJTU1AF-CRF-2016-004
• First Posted: February 20, 2017
• Last Update Posted: November 16, 2018
• Last Verified: October 2018

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:

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

Additional relevant MeSH terms:

Acute Coronary Syndrome; Syndrome; Depression; Depressive Disorder; Anxiety Disorders; Disease; Pathologic Processes; Behavioral Symptoms; Mood Disorders; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Antidepressive Agents; Psychotropic Drugs