Acute Coronary SyndromeNCT03057691
The Impact of Depression and/or Anxiety on PCI Patients
An observational study of Acute Coronary Syndrome and Depression, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Depression, Anxiety
- What is being tested?
- antidepressive and anti-anxiety therapy
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2017to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention
Who may be able to join
- 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
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Juan Zhou, Professor, 0086-18191037350, 1306899042@qq.com
About this study
Official title: The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions
The purpose of this study is to evaluate how depression and/or anxiety could effect the prognosis of the patients post-ACS after PCI.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Depression, Anxiety
- Being tested
- antidepressive and anti-anxiety therapy
- Keywords
- Acute Coronary Syndrome, Depression, Anxiety, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events
- Medical subject headings
- Acute Coronary Syndrome, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antidepressive and anti-anxiety therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: antidepressive and anti-anxiety therapy | |
| Anxiety | patients suffered from post-ACS anxiety who have undergone PCI Receives: Other: antidepressive and anti-anxiety therapy | |
| Depression with anxiety | patients suffered from post-ACS depression with anxiety who have undergone PCI Receives: Other: antidepressive and anti-anxiety therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
death, myocardial infarction, stroke, angina pectoris, revascularization.
Measured: 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
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)
Measured: 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
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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start11 Mar 2017
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Zuyi Yuan, Professor, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057691
- Sponsor's protocol ID
- XJTU1AF-CRF-2016-004
- Status last verified
- Oct 2018
- First submitted
- 15 Feb 2017
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26562328Lichtman 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.
PubMed 24566200Oldroyd 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.
PubMed 24237848Regan 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.
PubMed 18953212Ossola 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.
PubMed 26144582Huffman 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.
PubMed 20505844Celano 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.
PubMed 26678632Nezafati MH, Vojdanparast M, Nezafati P. Antidepressants and cardiovascular adverse events: A narrative review. ARYA Atheroscler. 2015 Sep;11(5):295-304.
PubMed 26715935Marke 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.
PubMed 26613707Xiao 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.
PubMed 31492778
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Depression and/or Anxiety on Patients With Acute Coronary Syndrome After Percutaneous Coronary Interventions
- ClinicalTrials.gov ID
- NCT03057691
- Acronym / sponsor ID
- XJTU1AF-CRF-2016-004
- Conditions
- Acute Coronary Syndrome, Depression, Anxiety
- Keywords
- Acute Coronary Syndrome, Depression, Anxiety, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- 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
- Study start
- 11 Mar 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No depression/anxiety | – | –patients suffered from ACS who have undergone PCI without depression or anxiety |
| Depression | – | Other: antidepressive and anti-anxiety therapypatients suffered from post-ACS depression who have undergone PCI |
| Anxiety | – | Other: antidepressive and anti-anxiety therapypatients suffered from post-ACS anxiety who have undergone PCI |
| Depression with anxiety | – | Other: antidepressive and anti-anxiety therapypatients suffered from post-ACS depression with anxiety who have undergone PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffered from acute coronary syndrome after percutaneous coronary intervention
Key inclusion criteria (11 listed)
- 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
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antidepressive and anti-anxiety therapyThese 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. | Other | Anxiety, Depression, Depression with anxiety |
Primary outcome
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.
2 secondary outcomes
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
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 and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Background: PubMed 26562328Teply 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.
- Background: PubMed 24566200Lichtman 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.
- Background: PubMed 24237848Oldroyd 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.
- Background: PubMed 18953212Regan 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.
- Background: PubMed 26144582Ossola 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.
- Background: PubMed 20505844Huffman 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.
- Background: PubMed 26678632Celano 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.
- Background: PubMed 26715935Nezafati MH, Vojdanparast M, Nezafati P. Antidepressants and cardiovascular adverse events: A narrative review. ARYA Atheroscler. 2015 Sep;11(5):295-304.
- Background: PubMed 26613707Marke 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.
- Derived from this study: PubMed 31492778Xiao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zuyi Yuan, Professor study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Depression, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Zhou, Professor (0086-18191037350, 1306899042@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03057691, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.