The Relationship Between Anxiety, Depression and Stent Restenosis After Percutaneous Coronary Intervention

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease; Percutaneous Coronary Intervention

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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Zhuo Liu, MD; Phone Number: +86-03355908581; Email: liuzhuo_2008@yeah.net
• Study Contact Backup: Name: Ximing Qi; Phone Number: +86-03355908500; Email: ximingqi123@sina.com

Study Locations

• China
  • Hebei
    • Qinhuangdao, Hebei, China, 066000
      • Recruiting
      • 中国
      • Contact: Zhuo Liu; Phone Number: +8603355908581; Email: liuzhuo2011@yeah.net
      • Contact: 中国; Phone Number: +8603355908581

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other adverse cardiac events	Including death, recurrent myocardial infarction, and recurrent angina	1 year

Collaborators and Investigators

• Sponsor: The First Hospital of Qinhuangdao

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: March 20, 2021
• First Submitted That Met QC Criteria: March 20, 2021
• First Posted (Actual): March 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Coronary heart disease; In-stent restenosis; Anxiety state; Depressive slale
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2021W123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No