Ignite Creation Date:
2024-05-05 @ 9:03 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00806312
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2008-12-09
Brief Title:
The Expression and Significance of MiRNA
Sponsor:
Megan Ballinger
Organization:
Ohio State University
Study Overview
Official Title:
The Expression and Significance of miRNA Profile and Markers of Inflammation in Patients With Pulmonary Arterial Hypertension
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
It is not always known what causes PAH or what the best treatment is The doctors doing this study would like to understand more about why some people develop PAH and other do not They also would like to learn more about which treatments might help PAH and which people might respond better to treatments
Doctors think that testing certain substances found in blood cells might help answer these questions These substances are normally released by our bodies to protect us from infection and to tell the difference between normal and foreign substances in our body Finally a new test will study very small molecules called microRNA that control how our genes are expressed This study is being done to see if blood samples can be tested to determine who might develop PAH how well drugs will work to treat PAH and to learn more about the development of PAH
Doctors think that testing certain substances found in blood cells might help answer these questions These substances are normally released by our bodies to protect us from infection and to tell the difference between normal and foreign substances in our body Finally a new test will study very small molecules called microRNA that control how our genes are expressed This study is being done to see if blood samples can be tested to determine who might develop PAH how well drugs will work to treat PAH and to learn more about the development of PAH
Detailed Description:
You will be asked to donate blood when you have your right heart catheterization and also at the 3-4 month follow-up visit The amount of blood collected during your heart catheterization is about 20cc about 4 teaspoons This blood is discarded as part of the clinical catheterization procedure but we are asking that we use it for this research study Then at the follow-up right heart catheterization you will be asked to donate 20 cc which is about 4 teaspoons of blood
If the second right heart is not required for clinical purposes then you will be asked to give a blood sample during your 3-4 month follow up clinic visit
If you require an additional right heart catheterization within one year we will ask that you donate additional samples at the subsequent RHC
Other data collected as part of your clinical care such as medical history chest x-ray picture of your lungs echocardiogram picture of your heart ventilation perfusion scan determines how much blood goes to your lungs chest CT thin pictures of my lungs as slices pulmonary function tests breathing tests and lab blood tests will be used as part of this research
If the second right heart is not required for clinical purposes then you will be asked to give a blood sample during your 3-4 month follow up clinic visit
If you require an additional right heart catheterization within one year we will ask that you donate additional samples at the subsequent RHC
Other data collected as part of your clinical care such as medical history chest x-ray picture of your lungs echocardiogram picture of your heart ventilation perfusion scan determines how much blood goes to your lungs chest CT thin pictures of my lungs as slices pulmonary function tests breathing tests and lab blood tests will be used as part of this research
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None