NCT03153878

Brief Summary

This is a registry study of the natural course of unruptured intracranial aneurysms (UIA). In addition, the investigators will analyze the benefit-risk of antithrombotic or anticoagulant therapy in patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease. The investigators aim to use research data to create a China national database of UIA

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

May 11, 2017

Last Update Submit

May 11, 2017

Conditions

Intracranial AneurysmNatural HistoryIschemic Heart DiseaseIschemic Cerebrovascular Disease

Keywords

Unruptured Intracranial AneurysmBenefit-riskIschemic heart diseaseIschemic cerebrovascular diseaseAntithromboticAnticoagulantPeople's Republic of ChinaMulticenter Studies

Outcome Measures

Primary Outcomes (2)

  • Aneurysm rupture

    Aneurysm rupture

    Up to 4 years or time of aneurysm repair surgery

  • Morphological changes of aneurysms

    maximum diameter increase ≥ 1mm or appearance of a daughter sac

    Up to 4 years or time of aneurysm repair surgery

Secondary Outcomes (2)

  • Acute myocardial infarction

    Up to 4 years]

  • New onset ischemic stroke

    Up to 4 years]

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients with unruptured intracranial aneurysms associated with ischemic heart disease or ischemic cerebrovascular disease,who accept antithrombotic or anticoagulant therapy

You may qualify if:

  • Diagnosis of untreated unruptured intracranial aneurysm (by CTA, MRA or DSA);
  • Patient with premorbid mRS of 3 or less;
  • Patient older than 14years;
  • Patient consenting to participate to the study;
  • Patients with a definite history of ischemic heart disease or ischemic stroke who accept antithrombotic or anticoagulant therapy for secondary pevention

You may not qualify if:

  • Subarachnoid hemorrhage with unknown causes;
  • \- Page 4 of 4 \[DRAFT\] - 2. Patient with other cerebral arteriovenous malformations or cerebral arteriovenous fistulas; 3. Patient with malignant tumor; 4. Target aneurysm is fusiform, traumatic, mycotic, or dissecting related; 5. Inability to obtain informed consent; 6. Patients with a life expectancy less than 1 year; 7. Participating in the other clinical studies of intracranial aneurysm; 8. Refusal of follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms--risk of rupture and risks of surgical intervention. N Engl J Med. 1998 Dec 10;339(24):1725-33. doi: 10.1056/NEJM199812103392401.

    PMID: 9867550BACKGROUND

  • Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.

    PMID: 12867109BACKGROUND

  • UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.

    PMID: 22738097BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Intracranial AneurysmMyocardial Ischemia

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesHeart Diseases

Study Officials

  • Min He, M.D.

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Zhiyong Liu, M.D, Ph.D

CONTACT

+8613658021726doctor_lzy@163.com

Jin Li, M.D, Ph.D

CONTACT

+13683482059jimlijin76@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research associate

Study Record Dates

First Submitted

May 11, 2017

First Posted

May 15, 2017

Study Start

June 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

May 15, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

share the original data 5 years after the study completion