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
  Purpose

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.


Condition
Pulmonary Arterial Hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Expression and Significance of miRNA Profile and Markers of Inflammation in Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

blood


Estimated Enrollment: 200
Study Start Date: July 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806312

Contacts
Contact: Janice E. Drake, CRRT 614-366-2287 janice.drake@osumc.edu
Contact: Melissa Michetti, CCRP 614-366-2761 melissa.michetti@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Principal Investigator: Namita Sood, MD         
Sponsors and Collaborators
Namita Sood
Investigators
Principal Investigator: Namita Sood, MD Ohio State University
  More Information

No publications provided

Responsible Party: Namita Sood, Namita Sood M.D., The Ohio State University
ClinicalTrials.gov Identifier: NCT00806312     History of Changes
Other Study ID Numbers: 2008H0070
Study First Received: December 9, 2008
Last Updated: March 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
MiRNA
pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2014