Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | May 2010 |
| End Date: | May 2014 |
| Contact: | Jonathan Rich, MD |
| Email: | jonathan.rich@uchospitals.edu |
| Phone: | (773) 702-5589 |
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.
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.
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
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