Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation

April 15, 2022 updated by: Martin Sinn, Universitätsklinikum Hamburg-Eppendorf
To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We hypothesized that a diffuse interstitial myocardial fibrosis may be present in AR patients who experience early systolic LV dysfunction after aortic valve surgery. We aimed to evaluate the association between preoperative cardiac T1 mapping for detection of myocardial fibrosis and early systolic LV dysfunction after surgery for aortic regurgitation.

Study Type

Observational

Enrollment (Actual)

40

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 40 consecutive AR patients referred for aortic valve surgery were included.

Description

Inclusion Criteria:

  • Consecutive patients with severe aortic regurgitation referred for aortic valve surgery were prospectively enrolled in the study.

Exclusion Criteria:

  • history of coronary artery disease
  • acute aortic valve disease (i.e., type A aortic dissection or infectious endocarditis)
  • common contraindications for MRI such as severe obesity and metallic foreign bodies.

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
Intervention / Treatment
Patients prior to aortic valve surgery
Procedure: aortic valve surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Native T1
Time Frame: baseline (Prior surgery)
Measured with MRI
baseline (Prior surgery)

Collaborators and Investigators

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

Sponsor

Universitätsklinikum Hamburg-Eppendorf

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)

July 1, 2016

Primary Completion (ACTUAL)

August 29, 2019

Study Completion (ACTUAL)

March 13, 2020

Study Registration Dates

First Submitted

April 11, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (ACTUAL)

April 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 15, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAV_T1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD can be shared anonymized upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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