Pulmonary Idiopathic Arterial HypertensionNCT00551408
Endothelial Progenitor Cells and Pulmonary Idiopathic Arterial Hypertension
An observational study of Pulmonary Idiopathic Arterial Hypertension, run by Unidad de Investigacion Clinica en Medicina S.C. at 1 site in Mexico.
Trial summary
Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair. Current evidence established that endothelial progenitor cells (EPC) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pulmonary Idiopathic Arterial Hypertension
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2007to Oct 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with IPAH between 18 and 70 years of age of either gender were invited to participate in the study
Who may be able to join
- Patients were included in the study if they were in The WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization. The ability to walk >50 m during a standardized 6-min walk test.
Who cannot join
- Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, major bleeding requiring blood transfusion,renal dysfunction, and evidence for malignant diseases were excluded.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigacion Clinica en Medicina SC.
Monterrey, Nuevo León, 64020
About this study
Official title: The Determination of Endothelial Progenitor Cells in Pulmonary Idiopathic Arterial Hypertension.
Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair.
Current evidence established that endothelial progenitor cells (EPC) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. However EPC in the setting of PAH is less well established. The target of this study is to demonstrate if the number of EPC is increased in a mexican population of patients with PAH.
- Medical subject headings
- Familial Primary Pulmonary Hypertension
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 |
|---|---|---|
| A | 20 patients with idiopathic pulmonary arterial hypertension in the WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization able to walk >50 m during a standardized 6-min walk test. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2007 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Idiopathic Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unidad de Investigacion Clinica en Medicina S.C.
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dr. Carlos jerjes-Sanchez Diaz, Unidad de Investigacion Clinica en Medicina S.C.
- Investigators
- Carlos J Sanchez Diaz, MD., Principal investigator, Unidad de Investigacion Clinica en Medicina SC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00551408
- Sponsor's protocol ID
- UDICEM07-012
- Other IDs
- 07-012
- Status last verified
- Oct 2018
- First submitted
- 29 Oct 2007
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determination of Endothelial Progenitor Cells in Pulmonary Idiopathic Arterial Hypertension.
- ClinicalTrials.gov ID
- NCT00551408
- Acronym / sponsor ID
- UDICEM07-012
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Unidad de Investigacion Clinica en Medicina S.C.Research network
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 31 Oct 2007 (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.
Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair.
Current evidence established that endothelial progenitor cells (EPC) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. However EPC in the setting of PAH is less well established. The target of this study is to demonstrate if the number of EPC is increased in a mexican population of patients with PAH.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –20 patients with idiopathic pulmonary arterial hypertension in the WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization able to walk >50 m during a standardized 6-min walk test. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with IPAH between 18 and 70 years of age of either gender were invited to participate in the study
Key inclusion criteria (1 listed)
- Patients were included in the study if they were in The WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization. The ability to walk >50 m during a standardized 6-min walk test.
Key exclusion criteria (1 listed)
- Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, major bleeding requiring blood transfusion,renal dysfunction, and evidence for malignant diseases were excluded.
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
Not reported in the source record.
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 16 Oct 2018.
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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.
Carlos J Sanchez Diaz, MD. principal investigator
Unidad de Investigacion Clinica en Medicina SC.
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 Pulmonary Idiopathic Arterial Hypertension, run by Unidad de Investigacion Clinica en Medicina S.C. at 1 site in Mexico.
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 1 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 16 Oct 2018. 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 Mexico. 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.
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 16 Oct 2018.