Cardiovascular DiseasesGenotypeNCT00616369
Identification of Genetic Markers for Cardiopulmonary Diseases (Genotype)
An observational study of Cardiovascular Diseases, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study is designed to investigate whether an association exists between certain genes/protein levels and the development of various cardiopulmonary diseases. It is hoped that this project will provide valuable insight into the understanding of these diseases. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 255 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.
Who may be able to join
- Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama @ Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Identification of Genetic Markers for Cardiopulmonary Diseases
This study is designed to investigate whether an association exists between certain genes/protein levels and the development of various cardiopulmonary diseases. It is hoped that this project will provide valuable insight into the understanding of these diseases.
Read the detailed description
There are two main groups of participants in this trial:
Group 1: Patients that are enrolled in either or both of previous studies: X980515002 study (Identification of Genetic Markers for Primary Pulmonary Hypertension) and or X030403017 study (Pulmonary Arterial Hypertension (PAH) Database)
Group 2: Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age
Group 1: For those patients who have had blood samples drawn as a result of participating in the current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. With each disease therapy change, blood will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. These current X980515002 participants WILL sign a consent form to participate in this new trial. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study.
For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants WILL also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. With each disease therapy change, a 12mL (less than 3 teaspoons) blood sample will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. As for the X030403017 expired patients, we would like to use the previously obtained data in part for this study that was collected as a result of the X030403017 study.
Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits.
- Conditions
- Cardiovascular Diseases
- Keywords
- pulmonary hypertension, hypertension, cardiomyopathy, arrhythmias
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Pulmonary, Hypertension, Cardiomyopathies, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | I: For those patients who have had blood samples drawn as a result of participating in current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants will also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study. | |
| 2 | II: Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in NYHA WHO Functional Class,right and left heart catheterization measurements, echocardiograms, 6MWT, laboratory values, electrocardiograms, x-ray's, MRI's, CT Scans, Pulmonary Function Tests, and Ventilation Perfusion Scans will be assessed.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert C Bourge, MD, Principal investigator, University of Alabama at Birmingham Division of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616369
- Sponsor's protocol ID
- X070116004
- Acronym
- Genotype
- Status last verified
- Jan 2016
- First submitted
- 5 Feb 2008
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Genetic Markers for Cardiopulmonary Diseases
- ClinicalTrials.gov ID
- NCT00616369
- Acronym / sponsor ID
- Genotype / X070116004
- Conditions
- Cardiovascular Diseases
- Keywords
- pulmonary hypertension, hypertension, cardiomyopathy, arrhythmias
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to investigate whether an association exists between certain genes/protein levels and the development of various cardiopulmonary diseases. It is hoped that this project will provide valuable insight into the understanding of these diseases.
Detailed description
There are two main groups of participants in this trial:
Group 1: Patients that are enrolled in either or both of previous studies: X980515002 study (Identification of Genetic Markers for Primary Pulmonary Hypertension) and or X030403017 study (Pulmonary Arterial Hypertension (PAH) Database)
Group 2: Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age
Group 1: For those patients who have had blood samples drawn as a result of participating in the current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. With each disease therapy change, blood will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. These current X980515002 participants WILL sign a consent form to participate in this new trial. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study.
For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants WILL also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. With each disease therapy change, a 12mL (less than 3 teaspoons) blood sample will be drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. As for the X030403017 expired patients, we would like to use the previously obtained data in part for this study that was collected as a result of the X030403017 study.
Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –I: For those patients who have had blood samples drawn as a result of participating in current protocol, Identification of Genetic Markers for Primary Pulmonary Hypertension study (X980515002), we would like to use their previously obtained blood and continue to draw samples (12mL; less than 3 tablespoons) ONLY if they change disease therapies. For those patients who participated in Pulmonary Arterial Hypertension (PAH) Database study (X030403017), these participants will also sign a consent form to participant in this new trial. We would like to use the previously obtained data from the X030403017 in part with this study. As for the X980515002 expired patients, we would like to use the previously obtained data ONLY in part for this study that was collected as a result of the X980515002 study. |
| 2 | – | –II: Group 2: After signing a consent form, these participants will have a 12mL (less than 3 teaspoons) blood sample drawn at baseline, at 3-4 month, at 6-8 month, at 12 month, and at 24 month visits. With each disease therapy change, the blood draws (12mL samples) will begin again at baseline and continue through the 3-4, 6-8, 12, and 24 month visits. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.
Key inclusion criteria (1 listed)
- Participants with the diagnosis of any of the previously listed Cardiopulmonary Diseases who are ≥15 years of age will be approached and offered the opportunity to participate in this study.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in NYHA WHO Functional Class,right and left heart catheterization measurements, echocardiograms, 6MWT, laboratory values, electrocardiograms, x-ray's, MRI's, CT Scans, Pulmonary Function Tests, and Ventilation Perfusion Scans will be assessed.
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C Bourge, MD principal investigator
University of Alabama at Birmingham Division of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in NYHA WHO Functional Class,right and left heart catheterization measurements, echocardiograms, 6MWT, laboratory values, electrocardiograms, x-ray's, MRI's, CT Scans, Pulmonary Function Tests, and Ventilation Perfusion Scans will be assessed. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.