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Completed

NCT Number: NCT06098066

Decoding Risks and Rewards in Ischemic Stroke Surgery

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.

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Key information

Conditions

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

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. rehospitalization

    Time frame: 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 outcomes

  1. Cardiac events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2023
First posted
Oct 24, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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