Decoding Risks and Rewards in Ischemic Stroke Surgery

NCT06098066 | Completed

• 1 other identifier: NS01
• Study Type: observational
• Target: 204,411
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Ischemic Cerebrovascular Disease; EC-IC Bypass; Carotid Endarterectomy; Carotid Artery Stenting; Nationwide Cohort Study; Risk-Benefit Analysis

Outcome Measures

Primary Outcomes (1)

• rehospitalization

  rehospitalization due to ischemic or hemorrhagic stroke

  Follow-up assessments were planned at 3 months, 6 months, 1 year, 2 years, and 3 years post-index date

Secondary Outcomes (1)

• Cardiac events

  Follow-up assessments were planned at 3 months, 6 months, 1 year, 2 years, and 3 years post-index date

Study Arms (4)

control

ECIC bypass

CEA

CAS

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The cohort comprises all inpatients hospitalized between January 1, 2001, and December 31, 2010, diagnosed with a first stenosis-occlusion ischemic stroke (ICD-9-CM codes 433-434). All participants underwent either a computed tomography (CT) scan or magnetic resonance imaging (MRI) within two days before or after hospital admission.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Researcher

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 24, 2023
• Study Start: May 1, 2020
• Primary Completion: May 30, 2020
• Study Completion: January 31, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

TW (1)