NCT00143858

Brief Summary

The purpose of this study is to determine the clinical usefulness of measuring the heart's pumping ability by measuring the Peripheral Pulse Volume (PPV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2004

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

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

First QC Date

August 31, 2005

Last Update Submit

August 6, 2009

Conditions

Peripheral Vascular Response

Keywords

Peripheral Pulse Volume

Interventions

Pulse Volume MeasurementDEVICE

patients will wear a newly designed calf monitor that will be hooked up to a computer that will monitor leg peripheral pulse volumes which will then be correlated to pressures obtained with Swan Ganz monitoring. The calf monitor is gut two bands with sensors that are wrapped around the ankle and below the knww

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who are having a right heart catherization done for other diagnostic purposes or patient in the critical care units who have Swan Ganz catheters in place for other medical management

You may qualify if:

  • Coronary care unit patients with indwelling right heart (Swan Ganz) catheters with or without intraaortic balloon assist pumping devices.
  • Congestive Heart Failure patients on and off various therapeutic inotropic agents with or without indwelling heart catheters
  • Cardiac catheterization laboratory patients undergoing prophylactic IABP in the presence of left main or diffuse unstable CAD
  • Chronic renal failure patients undergoing hemodialysis.
  • Peripheral Vascular Disease patients
  • Patients undergoing Tilt Table Testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • Marks LA. Digital enhancement of the peripheral admittance plethysmogram. IEEE Trans Biomed Eng. 1987 Mar;34(3):192-8. doi: 10.1109/tbme.1987.325944. No abstract available.

    PMID: 3570309BACKGROUND

Study Officials

  • Sebastian Palmeri, MD

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 2, 2005

Study Start

September 1, 2004

Study Completion

October 1, 2007

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

US(1)