Radiofrequency-based Speckle Tracking Echocardiography to Evaluate Diastolic Function

NCT01182805 | Completed Phase 1 Results

• 2 other identifiers: RF-SPEED5R44HL071379
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate a novel ultrasound system's ability to assess the relaxing properties of the heart compared to current techniques.

Conditions

Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (2)

• Diastolic Circumferential Strain Rate During Isovolumic Relaxation

  Diastolic circumferential strain rate during isovolumic relaxation is a novel measure of diastolic function that measures the rate of relaxation of the left ventricle during the interval of isovolumic relaxation (the period of active relaxation). We would expect that a higher value reflects better relaxation, and better diastolic function.

  Assessed from echo obtained at time of enrollment

• Early Diastolic Mitral Annular Velocity (E-prime) Using Tissue Doppler

  E-prime is a conventional commonly-used parameter of diastolic function. Higher values of E-prime typically reflect better diastolic function.

  Assessed from echo obtained at time of enrollment

Study Arms (1)

Single arm study.

OTHER

Device: Echocardiography system Ultra DCI Model 5000; Device: Echocardiography machine GE Vivid E9; Device: Diastolic function assessment

Interventions

Echocardiography system Ultra DCI Model 5000 DEVICE

Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.

Single arm study.

Echocardiography machine GE Vivid E9 DEVICE

Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.

Single arm study.

Diastolic function assessment DEVICE

Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.

Single arm study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled to undergo a clinically indicated left heart cardiac catheterization will be recruited for the study.

You may not qualify if:

• Suspected acute ST elevation myocardial infarction.
• Acute coronary syndrome with active ongoing chest pain
• Known or suspected acute aortic dissection
• Known or suspected cardiac tamponade
• Known history of unoperated constrictive pericarditis
• Known or suspected severe aortic stenosis or severe mitral regurgitation
• Heart rhythm other than sinus rhythm on pre-cath EKG
• Age \< 18 years old
• Unable to provide informed consent

Sponsors & Collaborators

• University of Michigan: lead
• Pixel Velocity, Inc. / Epsilon Imaging: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Michigan Cardiovascular Center

Ann Arbor, Michigan, 48109-5853, United States

Location

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Theodore J. Kolias, MD
• Organization: University of Michigan

tkolias@umich.edu

(734) 615-4907

Study Officials

• Theodore J Kolias, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 16, 2023
• Results First Posted: August 3, 2012

Record last verified: 2023-10

Locations

US (1)