NCT05382611

Brief Summary

To assess the expression of miRNA in patients with TAA, AAA in aneurysmatic tissue and to compare this expression with the healthy tissue in the same patient. In the same cohort, to asses the presence of miRNA in plasma and to compare with the control group. Over the period of three years,to follow subjects in order to assess if the presence of certain miRNAs speeds up or slows down the progression of disease. In patients with intracranial aneurysms to detect miRNA in plasma especially in patients with familial occurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 19, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

3.6 years

First QC Date

May 16, 2022

Last Update Submit

May 16, 2022

Conditions

Keywords

miRNA

Outcome Measures

Primary Outcomes (1)

  • The comparison of miRNA in healthy and aneurysmatic tissue

    miRNA will be compared in blood and in healthy and aneurysmatic tissue using ngs

    2020 at end of trial

Study Arms (2)

Patients Controls

Control group

Diagnostic Test: ngs next generation sequencing

Patients with aneurysma

Patients with aneurysma

Diagnostic Test: ngs next generation sequencing

Interventions

the samples from aneurysmatic tissue and healthy aortic tissue will be investigated using NGS

Patients ControlsPatients with aneurysma

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study group will be made up of 50 subjects followed for the diagnosis of AAA or TAA and 20 patients with intracranial aneurysm. The control group comprises 20 subjects in total and will be made up of patients who are treated for lipid metabolism disorder

You may qualify if:

  • years of age or older
  • Patient willing and able to sign clinical trial Informed Consent
  • Patient with AAA or TAA who require an open surgical procedure, or patient with intracranial aneurysm indicated for radiological intervention

You may not qualify if:

  • \. Patient with multiorgan failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Na Homolce Hospital

Prague, 15030, Czechia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Aneurysmatic tissue, healthy tissue and blood

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

May 16, 2022

First Posted

May 19, 2022

Study Start

May 19, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Locations