Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing
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Purpose
Subjects in this study have been diagnosed with pulmonary hypertension (PH) and their doctors have referred them for a right heart catheterization (RHC). Heart catheterization involves inserting an IV (a needle with a small tube) into a vein in the neck. A long, narrow tube, called a catheter, is guided through the IV into the blood vessel and guided to the heart (sometimes this procedure can be done through a vein in the groin instead). Once the catheter is in place, small instruments can be inserted into the catheter to measure the pressures in different areas of the heart. These measurements can help the doctor diagnose possible problems with the heart functioning.
The purpose of this study is to evaluate the measurements provided by a device, called Noninvasive Cardiac Output Monitoring (NICOM). The NICOM device is non-invasive which means the investigators do not have to go inside the body to obtain the heart pressure measurements. While the device has been approved for use in any patient, it remains possible that patients with PH will have differences in the way the device calculates measurements. In this study, the investigators will compare the in-the-body (right heart catheterization) measurements to the non-invasive, outside-body measurements provided by the NICOM device to evaluate any differences.
The NICOM device is approved by the US Food and Drug Administration (FDA) to measure heart pressures. This device is usually used when a patient can't undergo a right heart catheterization. In this study, the investigators are using the device to gather heart pressure measurements for research during the right heart catheterization procedure that is scheduled as part of the patients' normal, routine care. The research data is being used to devise better, less invasive ways to assess disease severity, track disease progression and evaluate response to therapy. The NICOM device is made by Cheetah Medical.
| Condition |
|---|
|
Pulmonary Hypertension |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing |
- To determine the accuracy of a noninvasive method of measuring cardiac output as compared to the standard invasive approach using thermodilution in patients with pulmonary hypertension [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| subjects with PH undergoing right heart catheterization |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
We will enroll 100 consecutive patients referred to the Pulmonary Hypertension Center and scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH.
Inclusion Criteria:
- 18 years old and up
- have Pulmonary Hypertension (PH)
- Scheduled for cardiac catheterization with right heart catheterization and acute vasodilator testing as part of their evaluation of PH
Exclusion Criteria:
- unable or unwilling to give informed consent
Contacts and Locations| Contact: Jonathan Rich, MD | (773) 702-5589 | jonathan.rich@uchospitals.edu |
| Contact: Stuart Rich, MD | (773) 702-5589 | srich@medicine.bsd.uchicago.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Jonathan Rich, MD 773-702-5589 jonathan.rich@uchospitals.edu | |
| Contact: Staurt Rich, MD (773) 702-5589 srich@medicine.bsd.uchicago.edu | |
| Principal Investigator: Stephen Archer, MD | |
| Sub-Investigator: Jonathan Rich, MD | |
| Sub-Investigator: Stuart Rich, MD | |
| Principal Investigator: | Stephen Archer, MD | University of Chicago |
More Information
No publications provided
| Responsible Party: | Stuart Rich, Professor of Medicine, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01275690 History of Changes |
| Other Study ID Numbers: | 10-179-B |
| Study First Received: | January 10, 2011 |
| Last Updated: | June 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
cardiac pulmonary hypertension To determine the accuracy of a noninvasive method of measuring cardiac output as compared to the standard invasive approach in patients with PH |
Additional relevant MeSH terms:
|
Hypertension Hypertension, Pulmonary Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013