The Expression and Significance of MiRNA

NCT ID: NCT00806312

Last Updated: 2021-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2018-08-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Arterial Hypertension

Keywords

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MiRNA pulmonary arterial hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Megan Ballinger

OTHER

Sponsor Role lead

Responsible Party

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Megan Ballinger

Research Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Namita Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2008H0070

Identifier Type: -

Identifier Source: org_study_id