Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging

July 21, 2020 updated by: Chang Gung Memorial Hospital
We prospectively collected information on consecutive patients who had been evaluated using 4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020. Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient was excluded due to fever at the scheduled time, and another was unable to lie down due to complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous administration of contrast media, followed by 4D PC-MRI to assess aortic pathology

Study Type

Observational

Enrollment (Anticipated)

50

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

  • Taiwan
    • Chiayi County
      • Chiayi City, Chiayi County, Taiwan, 61362
        • Recruiting
        • Yao-Kuang Huang
        • Contact:

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 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with aortic disease

Description

Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections. The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke volume
Time Frame: 5 years
anatomic/hemodynamic parameter
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse event
Time Frame: 5 years
diagnostic function
5 years

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

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 (Actual)

March 1, 2018

Primary Completion (Actual)

February 12, 2020

Study Completion (Anticipated)

December 12, 2025

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 22, 2020

Study Record Updates

Last Update Posted (Actual)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019011776B0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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