CoHOrt of Cerebral CavernOus maLformATion: multicEnter Prospective Observational Study (CHOCOOATE)

May 9, 2022 updated by: Jeong Eun Kim, Seoul National University Hospital

A Prospective Study for the Natural History and the Risk Factors of Prospective Symptomatic Hemorrhage in Adult Patients With Cerebral Cavernous Malformation

The aim of this prospective study is to reveal the natural history of symptomatic hemorrhage in adult patients with cerebral cavernous malformation with the goal of informing the treatment plan.

Study Overview

Status

Active, not recruiting

Detailed Description

Cerebral cavernous malformation Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cerebral cavernous malformation. If the patient had multiple cavernous malformations, index cavernous malformation would be enrolled. Index lesion will be determined according to the criteria.

  • Index lesion decision criteria I. Symptomatic II. Asymptomatic (priorities are as follows)

    1. Previous bleed
    2. Brain stem location
    3. Deep nuclei (thalamus, caudate, basal ggl, hypothalamus)
    4. Periventricular
    5. Largest

All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.

Study Type

Observational

Enrollment (Actual)

228

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Jeju, Korea, Republic of
        • Jeju National University Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of, 04401
        • Soonchunhyang University Hospital Seoul
    • Kangwon
      • Chuncheon, Kangwon, Korea, Republic of
        • Kangwon National University Hospital
    • Kanwon
      • Chuncheon, Kanwon, Korea, Republic of
        • HUMC-Chuncheon Sacred Heart Hospital
    • Kyungkido
      • Ilsan, Kyungkido, Korea, Republic of
        • DongGuk University
    • South Gyeongsang
      • Jinju, South Gyeongsang, Korea, Republic of, 52727
        • Gyeongsang National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Investigators defined the cohort population as adults( more than 18 years old) with newly diagnosed cerebral cavernous malformation who agree to participate.

Description

Inclusion Criteria:

  • Patients with newly diagnosed cerebral cavernous malformation who agreed to participate.
  • 18 years old or more

Exclusion Criteria:

  • Patients who underwent treatment(surgery or radiosurgery) for cavernous malformation
  • Patients who are accompanied by other serious medical problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cerebral cavernous malformation
Patients with newly diagnosed, cerebral cavernous malformation who will visit one of the study centers during the period from June 2016 to December 2017. Patients would be eligible for enrollment if they were 18 years of age or older and had at least 1 cavernous malformation. All patients who would visit a study center during the enrollment period and meet these criteria will be asked to join the study. The cohort will consists of patients who agree to participate. Target population of this study is 228 patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic hemorrhage
Time Frame: 5 year
hemorrhage due to rupture of cavernous malformation
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptomatic hemorrhage
Time Frame: 1 year
hemorrhage due to rupture of cavernous malformation
1 year
All hemorrhagic event including radiologic rupture + newly appeared neurologic symptom
Time Frame: 1 year
hemorrhage without symptom
1 year
All hemorrhagic event including radiologic rupture
Time Frame: 5 year
all hemorrhagic events
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 27, 2016

Study Record Updates

Last Update Posted (Actual)

May 12, 2022

Last Update Submitted That Met QC Criteria

May 9, 2022

Last Verified

May 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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