Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

NICOM in Pregnant Women With Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03616730
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Florio, Saint Luke's Health System

Brief Summary:
An accepted "gold standard" for hemodynamic monitoring in women with both healthy and diseased hearts is not currently available. Pregnancy is associated with significant hemodynamic changes, both during and following delivery, which can be even more profound in the structurally-abnormal heart. Clinical management of these women is based on surrogate markers of cardiac indices such as peripheral blood pressure, heart rate and oxygen saturation, rather than the use of invasive testing due to its associated complications. Echocardiography has largely replaced PAC in the obstetric population to measure cardiac output due to its non-invasive nature and good correlation with PAC18. However, its use is limited in the intrapartum period due to the need for clinical expertise in obtaining and interpreting the images. The proposed study has the potential to validate bio-reactance cardiac output monitoring using the NICOM against echocardiography for use in structurally normal and abnormal pregnant hearts in order to better drive goal-directed (specifically delivery mode) therapy through continuous hemodynamic monitoring during the second and third stages of labor, and 24 hours postpartum.

Condition or disease Intervention/treatment
Heart Diseases in Pregnancy Congenital Heart Disease in Pregnancy Diagnostic Test: NICOM (non-invasive cardiac output monitor)

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Validation of a Non-invasive Cardiac Output Monitor (NICOM) in Pregnant Women With Structural Heart Disease
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Group/Cohort Intervention/treatment
Heart Disease in pregnancy group
Fifty women will be recruited with structurally and functionally abnormal hearts without a history of chronic hypertension, pre-gestational diabetes, multiple gestations, preeclampsia, autoimmune disease, and anyone with a history of cardiomyopathy but currently normal ejection fraction. Women who are unable to give informed consent will not be included.
Diagnostic Test: NICOM (non-invasive cardiac output monitor)
Transthoracic bio-reactance, or the non-invasive cardiac output measurement [NICOMTM, Cheetah Medical Inc., Portland, OR] system, is a new technique that is able to measure multiple hemodynamic parameters with four transdermal electrodes placed on the patients' thorax. It is based on frequency- and phase-modulation of the voltage signal measured in response to an applied transthoracic current. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations and is a FDA-approved device.

Control Group
Fifty women will be recruited with structurally normal hearts without a history of chronic hypertension, pre-gestational diabetes, multiple gestations, preeclampsia, autoimmune disease, and anyone with a history of cardiomyopathy but currently normal ejection fraction. Any woman on cardiac or antihypertensive medications (beta blockers, calcium channel blockers, hydralazine) will be excluded. Women who are unable to give informed consent will not be included.
Diagnostic Test: NICOM (non-invasive cardiac output monitor)
Transthoracic bio-reactance, or the non-invasive cardiac output measurement [NICOMTM, Cheetah Medical Inc., Portland, OR] system, is a new technique that is able to measure multiple hemodynamic parameters with four transdermal electrodes placed on the patients' thorax. It is based on frequency- and phase-modulation of the voltage signal measured in response to an applied transthoracic current. It has shown acceptable accuracy, precision and responsiveness for cardiac output monitoring in patients experiencing a wide-range of hemodynamic situations and is a FDA-approved device.




Primary Outcome Measures :
  1. Non-inferiority between NICOM and echocardiogram cardiac output measurements [ Time Frame: 3 year recruitment ]
    We will compare the cardiac output measurements obtained from the NICOM in each trimester with those obtained from the echocardiogram. We expect a mean percentage difference of < 30% between modalities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women.
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both healthy pregnant women and pregnant women with a history of heart disease will be recruited to participate in our observational, non-inferiority trial comparing the cardiac output measurements obtained by two different modalities. Women in their first trimester will be approached to participate. Any woman with a history of either structural or acquired heart disease will be recruited into the study group as described above. Women with structurally normal hearts in the first trimester who meet the aforementioned inclusion criteria will also be recruited to participate as the control group.
Criteria

Inclusion Criteria:

  • CONTROL GROUP:
  • singleton pregnancy
  • > 18 years of age
  • enrolled in first trimester of pregnancy
  • planning delivery at Saint Luke's Hospital of Kansas City
  • STUDY GROUP:
  • history of either congenital or acquired heart disease
  • singleton pregnancy
  • > 18 years of age
  • enrolled in first trimester of pregnancy
  • planning delivery at Saint Luke's Hospital of Kansas City

Exclusion Criteria:

Control group:

  • no history of either acquired or congenital heart disease
  • no hypertension, diabetes, multiple gestations, preeclampsia, or autoimmune disease
  • no use of antihypertensive medications
  • inability to give informed consent

Study Group:

  • no hypertension, diabetes, multiple gestations, preeclampsia, autoimmune disease
  • inability to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616730


Contacts
Layout table for location contacts
Contact: Karen L Florio, DO 816-932-0270 kflorio@saintlukeskc.org
Contact: Darcy White, RN 816-932-8141 darwhite@saintlukeskc.org

Locations
Layout table for location information
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Karen Florio, DO    816-932-0270    kflorio@saint-lukes.org   
Contact: April Smith    816-932-5019    aprlsmith1@saint-lukes.org   
Sponsors and Collaborators
Saint Luke's Health System
Investigators
Layout table for investigator information
Principal Investigator: Karen L Florio, DO Saint Luke's Hospital of Kansas City/UMKC Assistant Professor, MFM Division
  Study Documents (Full-Text)

Documents provided by Karen Florio, Saint Luke's Health System:
Informed Consent Form  [PDF] July 6, 2018


Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Karen Florio, Maternal-Fetal Medicine physician, Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT03616730     History of Changes
Other Study ID Numbers: 18-062
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Karen Florio, Saint Luke's Health System:
Non-invasive cardiac output monitor
Cardiac output

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Cardiovascular Diseases