Decoding Risks and Rewards in Ischemic Stroke Surgery

Sponsor

China Medical University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06098066

Collaborator

(none)

204,411

Enrollment

Location

Actual Duration (Months)

6190.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In the high-stakes battle against ischemic cerebrovascular disease, where every second counts and the margin for error is slim, how do the investigators tip the scales in favor of patient survival and improved outcomes? This groundbreaking study, the first nationwide, population-based analysis with long-term follow-up in an Asian context, dives deep into this critical question. Leveraging an expansive dataset from Taiwan's National Health Insurance Research Database, the investigators scrutinize the efficacy and risks of aggressive surgical interventions-specifically, EC-IC bypass, CEA, and CAS-in a cohort of over 84,000 patients.

This paper serves as a milestone, bridging the gap between medical idealism and clinical reality. It calls for a surgical renaissance, emphasizing the need for refining techniques and enhancing patient selection protocols. If participants're looking for a comprehensive, nuanced, and, above all, actionable insight into the surgical treatment of ischemic cerebrovascular disease, this is the study that could redefine the paradigm.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke

Study Design

Study Type:

Observational

Actual Enrollment :

204411 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Decoding the Surgical Enigma: A Groundbreaking Nationwide Study Unveils the Risks and Rewards of EC-IC Bypass, CEA, and CAS in Ischemic Cerebrovascular Disease

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

May 30, 2020

Actual Study Completion Date :

Jan 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
control
ECIC bypass
CEA
CAS

Outcome Measures

Primary Outcome Measures

rehospitalization [Follow-up assessments were planned at 3 months, 6 months, 1 year, 2 years, and 3 years post-index date]
rehospitalization due to ischemic or hemorrhagic stroke

Secondary Outcome Measures

Cardiac events [Follow-up assessments were planned at 3 months, 6 months, 1 year, 2 years, and 3 years post-index date]
congestive heart failure and acute myocardial infarction were also monitored throughout the study period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All participants underwent either a computed tomography (CT) scan or magnetic resonance imaging (MRI) within two days before or after hospital admission.

The date of the first ischemic stroke hospitalization served as the index event.

Among these patients, those who underwent surgical interventions post-hospitalization were categorized into three distinct groups: CEA (ICD-9-CM code 3812), CAS (ICD-9-CM code 3990), and EC-IC (ICD-9-CM code 3928), with the operation date being the index date.

Those who did not receive any surgical interventions were considered the non-intervention control group and had their first hospitalization date as the index date.

Exclusion Criteria:

patients with a history of: any stroke subtype (ICD-9-CM codes 430-434), Moyamoya disease (ICD-9-CM code 437.5), cancer (ICD-9-CM codes 140-239), trauma (various ICD-9-CM codes), transient ischemic attack (ICD-9-CM code 435), unruptured cerebral aneurysm (ICD-9-CM code 437.3), or subarachnoid hemorrhage (ICD-9-CM code 430).