Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shaanxi Provincial People's Hospital | OTHER |
| The First Hospital of Xi An City | UNKNOWN |
| Baoji Central Hospital | OTHER |
| General Hospital of Ningxia Medical University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate how depression and/or anxiety could effect the prognosis of the patients post-ACS after PCI.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Anxiety | patients suffered from post-ACS anxiety who have undergone PCI |
| |
| Depression with anxiety | patients suffered from post-ACS depression with anxiety who have undergone PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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
Not provided
Not provided
Not provided
Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Zhou, Professor | Contact | 0086-18191037350 | 1306899042@qq.com | |
| Wenyuan Li | Contact | 0086-15191903966 | lc3xlwy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zuyi Yuan, Professor | First Affiliated Hospital Xi'an Jiaotong University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26562328 | Background | 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. | |
| 24566200 | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000928 | Antidepressive Agents |
| ID | Term |
|---|---|
| D011619 | Psychotropic Drugs |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
|
| 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 |
| 24237848 | 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. |
| 18953212 | 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. |
| 26144582 | 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. |
| 20505844 | 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. |
| 26678632 | 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. |
| 26715935 | Background | Nezafati MH, Vojdanparast M, Nezafati P. Antidepressants and cardiovascular adverse events: A narrative review. ARYA Atheroscler. 2015 Sep;11(5):295-304. |
| 26613707 | 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. |
| 31492778 | Derived | 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. |
| D001526 |
| Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D020164 | Chemical Actions and Uses |