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CompletedNCT06098066Updated Oct 24, 2023

Decoding Risks and Rewards in Ischemic Stroke Surgery

An observational study in Ischemic Stroke, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by China Medical University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
204,411
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Stroke

Keywords

  • Ischemic Cerebrovascular Disease
  • EC-IC Bypass
  • Carotid Endarterectomy
  • Carotid Artery Stenting
  • Nationwide Cohort Study
  • Risk-Benefit Analysis
03

In context

Ischemic Stroke

2,595 studies on the registry are indexed under Ischemic Stroke; 932 are open to participants now.

This study's enrollment of 204,411 is above the median of 300 across 777 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
204,411 participants (actual)
Patient registry
No

Groups and cohorts

  • control
  • ECIC bypass
  • CEA
  • CAS
06

What researchers measure

Primary outcomes

  1. rehospitalization

    rehospitalization due to ischemic or hemorrhagic stroke

    Time frame: 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

    congestive heart failure and acute myocardial infarction were also monitored throughout the study period.

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

07

Study locations

1 site
  • China Medical University Hospital
    Taichung, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06098066
Lead sponsor
China Medical University Hospital
Responsible party
XianXiu Chen (Clinical Researcher, China Medical University Hospital) — Principal investigator
First posted
Oct 24, 2023
Start date
May 1, 2020
Primary completion
May 30, 2020
Completion
Jan 31, 2023
Last update
Oct 24, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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