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The Expression and Significance of MiRNA

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Namita Sood, The Ohio State University
ClinicalTrials.gov Identifier:
NCT00806312
First received: December 9, 2008
Last updated: March 27, 2014
Last verified: February 2014

December 9, 2008
March 27, 2014
July 2008
December 2015   (final data collection date for primary outcome measure)
evaluate if miRNa profile and markers of inflammation in patients with PAH. These profiles may enable us differentiate patients that have PAH. This may assist in predicting response to therapy and enable us to optimize their treatment. may also shed s [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00806312 on ClinicalTrials.gov Archive Site
Not Provided
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The Expression and Significance of MiRNA
The Expression and Significance of miRNA Profile and Markers of Inflammation in Patients With Pulmonary Arterial Hypertension

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood

Non-Probability Sample

We expect to enroll 200 patients, who have been referred to the Pulmonary Hypertension Clinic at the Ohio State University Medical Center, in this study. Patients who are ≥ 18 years of age, not pregnant, and undergoing right heart catheterization for PAH diagnosis as part of their clinical care will be approached for consent and participation in this study.

Pulmonary Arterial Hypertension
Not Provided
  • 1 PAH
    Patients who are ≥ 18 years of age, not pregnant, and undergoing right heart catheterization for PAH diagnosis as part of their clinical care will be approached for consent and participation in this study.
  • 2. Control
    Patients who present with symptoms of PAH and whose clinical right heart catheterization doesn't support this diagnosis will be enrolled as control subjects.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥ 18 years of age
  • Not pregnant
  • Undergoing right heart catheterization for PAH diagnosis

Exclusion Criteria:

  • Pregnant
Both
18 Years and older
No
Contact: Janice E. Drake, CRRT 614-366-2287 janice.drake@osumc.edu
Contact: Melissa Michetti, CCRP 614-366-2761 melissa.michetti@osumc.edu
United States
 
NCT00806312
2008H0070
No
Namita Sood, The Ohio State University
Namita Sood
Not Provided
Principal Investigator: Namita Sood, MD Ohio State University
Ohio State University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP