Coronary Heart DiseaseNCT04811976
The Relationship Between Anxiety, Depression and Stent Restenosis After Percutaneous Coronary Intervention
An observational study of Coronary Heart Disease and Percutaneous Coronary Intervention, run by The First Hospital of Qinhuangdao at 1 site in China.
Trial summary
Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, the incidence of ISR is as high as 10%-20% at 3-6 months after PCI. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Coronary Heart Disease, Percutaneous Coronary Intervention
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2019to 31 Mar 2022
- 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 55 to 75 years
- All sexes
- Adult, Older adult
Study population: The patients who underwent coronary angiography 1 year after PCI in the first hospital of Qinhuangdao from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Every 3 months until 12 months, the patients were consecutively recruited and followed up. Anxiety and depression were assessed using the Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and psychosomatic symptom scale at each follow-up timepoint.
Who may be able to join
- Clinical diagnosis of acute coronary syndrome The degree of coronary artery stenosis is greater than 90% The degree of coronary artery stenosis is greater than 75% and there is evidence of ischemia
Who cannot join
- Patients who did not receive stents for the first time Patients who had undergone coronary artery bypass grafting Patients with stent implantation due to stent stenosis Patients who had stents implanted for chronic complete coronary artery occlusion Patients with malignant tumors Patients with autoimmune diseases Patients with severe hepatic and renal insufficiency Patients with cardiomyopathy Patients with congenital heart disease Patients with valvular disease Patients present with acute stress events
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
中国
Qinhuangdao, Hebei, 066000
Zhuo Liu, +8603355908581, liuzhuo2011@yeah.net
中国, +8603355908581
About this study
Official title: The Effects of Anxiety and Depression on Stent Restenosis in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, the incidence of ISR is as high as 10%-20% at 3-6 months after PCI. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Current research shows that anxiety and depression are related to the increased risk of major adverse cardiac events and mortality in patients with acute myocardial infarction. But there remains a relative paucity of evidence for the association between anxiety and depression and in-stent restenosis (ISR) .So a retrospective cohort study was conducted in the first hospital of Qinhuangdao in 2015-2020. The patients who underwent coronary angiography 1 year after PCI in our hospital from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Logistic regression model was utilized for analyzing the association of depression and anxiety with the in-stent restenosis (ISR) after PCI.
Read the detailed description
Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, postoperative in-stent restenosis (ISR) is still inevitable. The incidence of ISR is as high as 10%-20% at 3-6 months after PCI. And its prevention and treatment is very difficult clinical problems. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Current research shows that anxiety and depression are related to the increased risk of major adverse cardiac events and mortality in patients with acute myocardial infarction. But there remains a relative paucity of evidence for the association between anxiety and depression and in-stent restenosis (ISR) .
A retrospective cohort study was conducted in the first hospital of Qinhuangdao in 2015-2020. The patients who underwent coronary angiography 1 year after PCI in our hospital from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Every 3 months until 12 months, the patients were consecutively recruited and followed up. Anxiety and depression were assessed using the Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and psychosomatic symptom scale at each follow-up timepoint. Relative clinical information was recorded and analyzed. Logistic regression model was utilized for analyzing the association of depression and anxiety with the in-stent restenosis (ISR) after PCI.
- Keywords
- In-stent restenosis, Coronary heart disease, Anxiety state, Depressive slale
- Medical subject headings
- Coronary Disease, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent restenosis
Because of the recurrence of symptoms, patients who have done the PCI more than 12 months do the coronary angiography in our hospital. Two interventionists were assigned to record the coronary angiography and complete the corresponding diagnosis in an independent way. If there was a difference in diagnosis, a third doctor was assigned to perform the correlation analysis and analyze and process the other data of the study subjects by blind method. In-stent restenosis was defined asin-stenosis of lumen diameter ≥50% occurred in the diseased vessels, including the coronary arteries in the stent and at both ends of the stent ≤5 mm from the edge of the stent.
Measured: 1 year
Secondary outcomes (1)
Other adverse cardiac events
Including death, recurrent myocardial infarction, and recurrent angina
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Dec 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Qinhuangdao
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811976
- Sponsor's protocol ID
- 2021W123
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 29 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anxiety and Depression on Stent Restenosis in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04811976
- Acronym / sponsor ID
- 2021W123
- Keywords
- In-stent restenosis, Coronary heart disease, Anxiety state, Depressive slale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The First Hospital of QinhuangdaoOther government
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 23 Mar 2021 (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.
Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, the incidence of ISR is as high as 10%-20% at 3-6 months after PCI. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Current research shows that anxiety and depression are related to the increased risk of major adverse cardiac events and mortality in patients with acute myocardial infarction. But there remains a relative paucity of evidence for the association between anxiety and depression and in-stent restenosis (ISR) .So a retrospective cohort study was conducted in the first hospital of Qinhuangdao in 2015-2020. The patients who underwent coronary angiography 1 year after PCI in our hospital from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Logistic regression model was utilized for analyzing the association of depression and anxiety with the in-stent restenosis (ISR) after PCI.
Detailed description
Percutaneous coronary intervention is currently one of the effective methods for the treatment of ACS. Unfortunately, postoperative in-stent restenosis (ISR) is still inevitable. The incidence of ISR is as high as 10%-20% at 3-6 months after PCI. And its prevention and treatment is very difficult clinical problems. So it is necessary to identify the potential risk factors to provide evidence for the prevention of ISR. Current research shows that anxiety and depression are related to the increased risk of major adverse cardiac events and mortality in patients with acute myocardial infarction. But there remains a relative paucity of evidence for the association between anxiety and depression and in-stent restenosis (ISR) .
A retrospective cohort study was conducted in the first hospital of Qinhuangdao in 2015-2020. The patients who underwent coronary angiography 1 year after PCI in our hospital from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Every 3 months until 12 months, the patients were consecutively recruited and followed up. Anxiety and depression were assessed using the Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and psychosomatic symptom scale at each follow-up timepoint. Relative clinical information was recorded and analyzed. Logistic regression model was utilized for analyzing the association of depression and anxiety with the in-stent restenosis (ISR) after PCI.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patients who underwent coronary angiography 1 year after PCI in the first hospital of Qinhuangdao from January 2015 to September 2020 were selected. Patients were divided into ISR and non-ISR groups depending on the follow-up coronary angiography results. Every 3 months until 12 months, the patients were consecutively recruited and followed up. Anxiety and depression were assessed using the Zung self-rating anxiety scale (SAS), self-rating depression scale (SDS) and psychosomatic symptom scale at each follow-up timepoint.
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute coronary syndrome The degree of coronary artery stenosis is greater than 90% The degree of coronary artery stenosis is greater than 75% and there is evidence of ischemia
Key exclusion criteria (1 listed)
- Patients who did not receive stents for the first time Patients who had undergone coronary artery bypass grafting Patients with stent implantation due to stent stenosis Patients who had stents implanted for chronic complete coronary artery occlusion Patients with malignant tumors Patients with autoimmune diseases Patients with severe hepatic and renal insufficiency Patients with cardiomyopathy Patients with congenital heart disease Patients with valvular disease Patients present with acute stress events
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-stent restenosis
Time frame: 1 year
Because of the recurrence of symptoms, patients who have done the PCI more than 12 months do the coronary angiography in our hospital. Two interventionists were assigned to record the coronary angiography and complete the corresponding diagnosis in an independent way. If there was a difference in diagnosis, a third doctor was assigned to perform the correlation analysis and analyze and process the other data of the study subjects by blind method. In-stent restenosis was defined asin-stenosis of lumen diameter ≥50% occurred in the diseased vessels, including the coronary arteries in the stent and at both ends of the stent ≤5 mm from the edge of the stent.
1 secondary outcome
Other adverse cardiac events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
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 Coronary Heart Disease and Percutaneous Coronary Intervention, run by The First Hospital of Qinhuangdao 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 1 inclusion and 1 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 29 Mar 2021. 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 Zhuo Liu, MD (+86-03355908581, liuzhuo_2008@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent restenosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2021.