Clinical trial NCT04811976: The Relationship Between Anxiety, Depression and Stent Restenosis After Percutaneous Coronary Intervention
Official title: The Effects of Anxiety and Depression on Stent Restenosis in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Percutaneous Coronary Intervention
Keywords: In-stent restenosis
Coronary heart disease
Anxiety state
Depressive slale
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2021-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: In-stent restenosis
timeFrame: 1 year
Secondary outcomes:
measure: Other adverse cardiac events
timeFrame: 1 year
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: 中国
state: Hebei
Study officials:
References: