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New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population (NATIONAL-1)

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ClinicalTrials.gov Identifier: NCT03153865
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Information provided by (Responsible Party):
Qinghai Huang, Changhai Hospital

Brief Summary:
This is a prospective, multicenter, observational study, aiming at comparing the Safety and effectiveness among the different surgical treatment of unruptured intracranial aneurysms in China, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.

Condition or disease
Unruptured Cerebral Aneurysm Treatment Strategy

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population
Estimated Study Start Date : June 2, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. mortality and disability [ Time Frame: through study completion, an average of 1 year ]
    the rate of death and disable


Secondary Outcome Measures :
  1. recurrence rate [ Time Frame: 1 month, 6 months and 1 year after surgery; ]
  2. progression of disease [ Time Frame: 1 month, 6 months and 1 year after conservative treatment; ]
    enlarge or ruptured of the aneurysm


Other Outcome Measures:
  1. the level of psychological states changes [ Time Frame: 1 month, 6 months and 1 year after been aware of the disease ]
    The Sheet for Affective Disorders was used to record the level of psychological states changes in every participant when they were aware of the disease.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients diagnosed with unruptured intracranial saccular aneurysm at all age.
Criteria

Inclusion Criteria:

  • patients diagnosed with unruptured intracranial saccular aneurysm on CTA, MRA or DSA.
  • patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria:

  • intracranial aneurysm correlating to AVM.
  • intracranial non-saccular aneurysm.
  • the rupture or unrpture of the aneurysm confirmed on CTA、MRA or DSA.
  • patients unwilling to participate in this clinical trial and attach to regular follow up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153865


Contacts
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Contact: Pengfei Yang, MD +86 15921196312 15921196312@163.com
Contact: Hongjian Zhang, MD +86 13961616656 chzhanghj2012@me.com

Locations
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China, Shanghai
Changhai Hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Pengfei Yang, MD    +86 15921196312    15921196312@me.com   
Sponsors and Collaborators
Changhai Hospital
Investigators
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Principal Investigator: Qinghai Huang, MD Changhai Hospital

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Responsible Party: Qinghai Huang, Principal Investigator, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03153865     History of Changes
Other Study ID Numbers: CHEC2017-073
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases