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

NCT04811976 | Unknown

• 1 other identifier: 2021W123
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Percutaneous Coronary Intervention

Keywords

In-stent restenosis; Coronary heart disease; Anxiety state; Depressive slale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Other adverse cardiac events

  1 year

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Qinhuangdao: lead

Study Sites (1)

中国

Qinhuangdao, Hebei, 066000, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Mental Disorders

Central Study Contacts

Zhuo Liu, MD

CONTACT

+86-03355908581; liuzhuo_2008@yeah.net

Ximing Qi

CONTACT

+86-03355908500; ximingqi123@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 23, 2021
• Study Start: December 1, 2019
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

CN (1)