Decoding Risks and Rewards in Ischemic Stroke Surgery

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098066
• Other study ID #: NS01
• Status: Completed
• Start date: May 1, 2020
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2023
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204411
• Est. completion date: January 31, 2023
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Ischemia
• Ischemic Stroke

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cardiac events	congestive heart failure and acute myocardial infarction were also monitored throughout the study period.	Follow-up assessments were planned at 3 months, 6 months, 1 year, 2 years, and 3 years post-index date