Comparison Study of Echocardiography and Cardiovascular M... | NCT04038879

Studies
Comparison Study of Echocardiography and Cardiovascular Magnetic Resonance Imaging in the Assessment of Mitral and Aortic Regurgitation

NCT04038879

Sponsor

Atlantic Health System

Status

Unknown status

Last Update Posted

Aug 6, 2019Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Mitral Regurgitation
Aortic Regurgitation

Interventions

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010Actual

Primary Completion Date

Jul 2023Estimated

Completion Date

Jul 2023Estimated

First Submitted Date

Jul 28, 2019

First Submission Date that Met QC Criteria

Jul 28, 2019

First Posted Date

Jul 31, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2019

Last Update Posted Date

Aug 6, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Seth Uretsky, Medical Director, Cardiovascular Imaging, Atlantic Health SystemPrincipal Investigator

Lead Sponsor

Atlantic Health SystemOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary treatment for patients determined to have severe aortic or mitral regurgitation is surgical repair or replacement their valves. The most commonly used tool to quantify the severity mitral and aortic regurgitation is echocardiography. Studies have shown that echocardiography may have significant limitations in quantifying regurgitant volume. MRI has recently been shown to easily and reproducibly quantify regurgitation. To better understand how to accurately quantify severity of regurgitation the investigators propose this study with the following aims: 1) compare MRI to echocardiography in the evaluation of regurgitant volume in patients with aortic or mitral regurgitation and 2) to assess which technique is better at predicting the response of the left ventricle to valve surgery.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitral/Aortic Regurgitation		Subjects identified with mitral or aortic regurgitation will be asked to undergo testing with trans thoracic echocardiogram, stress echocardiography, and cardiac MRI with and without contrast. In addition, patients will be asked to answer the KCC and EQ5DL questionnaires.	Diagnostic Test: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Diagnostic Test	MRI of the heart	Mitral/Aortic Regurgitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation of echocardiography and MRI	Correlation of echocardiography and MRI	6 month
Change in LV EDV post surgery	Change in LV EDV post surgery	6 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥18 years of age
Able to give informed consent
Referred for isolated aortic or mitral valve repair or replacement due to valve regurgitation

Exclusion Criteria:

Inability to provide consent.
Pregnancy
Claustrophobia
Metallic contraindications to MRI (e.g. noncompatible aneurysm clip etc)
Known intracardiac shunt
Planned concomitant cardiac surgical procedure such as coronary artery bypass, septal myomectomy, or other valve procedure.
More than mild mitral or aortic stenosis.
For patients enrolled with mitral regurgitation: greater than mild aortic regurgitation.
For patients enrolled with aortic regurgitation: greater than mild mitral regurgitation.
Hypertrophic cardiomyopathy.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects with mitral or aortic regurgitation

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Morristown Medical Center	Recruiting	Morristown	New Jersey	07960	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31005539	Background	Uretsky S, Aldaia L, Marcoff L, Koulogiannis K, Hiramatsu S, Argulian E, Rosenthal M, Gillam LD, Wolff SD. The Effect of Systolic Variation of Mitral Regurgitation on Discordance Between Noninvasive Imaging Modalities. JACC Cardiovasc Imaging. 2019 Dec;12(12):2431-2442. doi: 10.1016/j.jcmg.2019.02.014. Epub 2019 Apr 17.
29921479

ID	Term
D008944	Mitral Valve Insufficiency
D001022	Aortic Valve Insufficiency

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D000082862	Aortic Valve Disease