- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01275690
Noninvasive Cardiac Output Measurements in Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization With Acute Vasodilator Testing
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.
Studieöversikt
Status
Betingelser
Studietyp
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
---|
subjects with PH undergoing right heart catheterization
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: 2 years
|
2 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stephen Archer, MD, University of Chicago
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 10-179-B
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