AtherosclerosisNCT00251615
Calcium Channel Splice Variant Expression in Cardiovascular Disease and Aging
An observational study of Atherosclerosis, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to learn what changes in blood vessel contraction may occur as a result of a disease of the vessel that requires surgery. The study will examine the calcium channels present in the vessels being operated on, and the genes that may alter blood vessel function. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atherosclerosis
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2012
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for vascular surgery
Who may be able to join
- Ages 21 and older
- Scheduled for vascular surgery
Who cannot join
- Unwillingness to be subjected to diagnostic and/or therapeutic procedures that are deemed not necessary for clinical management
- Volunteers deemed too fragile to participate in the study by the principal investigator (PI) or the attending physician
- Inability to obtain informed consent from either the volunteer or the responsible party (durable power of attorney [DPA]) for the volunteer, with the volunteer's assent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute on Aging, Harbor Hospital
Baltimore, Maryland, 21225
About this study
The purpose of this study is to learn what changes in blood vessel contraction may occur as a result of a disease of the vessel that requires surgery. The study will examine the calcium channels present in the vessels being operated on, and the genes that may alter blood vessel function. Possible variation in these genes may change the kind of calcium channels present in blood vessels.
Read the detailed description
The goal of this study is to learn more about how blood vessels function and the mechanism that causes them to contract. The study will investigate the natural history of diseased blood vessel tissue and the calcium channels in the muscle part of the blood vessel. The study will also examine how genetics influences cardiovascular disease and its causes and treatments.
Patients scheduled for vascular surgery will be approached to participate in this study. During surgery, tissue fragments of diseased and marginal tissue will be obtained. A blood sample will be obtained at either the time of surgery or consent and genomic DNA will be extracted.
- Conditions
- Atherosclerosis
- Keywords
- vascular surgery, vascular aging, arterial aging, surgical tissue, Aging
- Medical subject headings
- Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startAug 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Samer Najjar, MD, Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251615
- Sponsor's protocol ID
- AG0058
- Status last verified
- Aug 2012
- First submitted
- 8 Nov 2005
- Last updated
- 6 Aug 2012
- Results posted
- No
Publications
Harry JB, Kobrinsky E, Abernethy DR, Soldatov NM. New short splice variants of the human cardiac Cavbeta2 subunit: redefining the major functional motifs implemented in modulation of the Cav1.2 channel. J Biol Chem. 2004 Nov 5;279(45):46367-72. doi: 10.1074/jbc.M409523200. Epub 2004 Aug 31.
PubMed 15339916Kobrinsky E, Tiwari S, Maltsev VA, Harry JB, Lakatta E, Abernethy DR, Soldatov NM. Differential role of the alpha1C subunit tails in regulation of the Cav1.2 channel by membrane potential, beta subunits, and Ca2+ ions. J Biol Chem. 2005 Apr 1;280(13):12474-85. doi: 10.1074/jbc.M412140200. Epub 2005 Jan 25.
PubMed 15671035Abernethy DR, Soldatov NM. Structure-functional diversity of human L-type Ca2+ channel: perspectives for new pharmacological targets. J Pharmacol Exp Ther. 2002 Mar;300(3):724-8. doi: 10.1124/jpet.300.3.724.
PubMed 11861774
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Channel Splice Variant Expression in Cardiovascular Disease and Aging
- ClinicalTrials.gov ID
- NCT00251615
- Acronym / sponsor ID
- AG0058
- Conditions
- Atherosclerosis
- Keywords
- vascular surgery, vascular aging, arterial aging, surgical tissue, Aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Aug 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 10 Nov 2005 (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.
The purpose of this study is to learn what changes in blood vessel contraction may occur as a result of a disease of the vessel that requires surgery. The study will examine the calcium channels present in the vessels being operated on, and the genes that may alter blood vessel function. Possible variation in these genes may change the kind of calcium channels present in blood vessels.
Detailed description
The goal of this study is to learn more about how blood vessels function and the mechanism that causes them to contract. The study will investigate the natural history of diseased blood vessel tissue and the calcium channels in the muscle part of the blood vessel. The study will also examine how genetics influences cardiovascular disease and its causes and treatments.
Patients scheduled for vascular surgery will be approached to participate in this study. During surgery, tissue fragments of diseased and marginal tissue will be obtained. A blood sample will be obtained at either the time of surgery or consent and genomic DNA will be extracted.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for vascular surgery
Key inclusion criteria (2 listed)
- Ages 21 and older
- Scheduled for vascular surgery
Key exclusion criteria (3 listed)
- Unwillingness to be subjected to diagnostic and/or therapeutic procedures that are deemed not necessary for clinical management
- Volunteers deemed too fragile to participate in the study by the principal investigator (PI) or the attending physician
- Inability to obtain informed consent from either the volunteer or the responsible party (durable power of attorney [DPA]) for the volunteer, with the volunteer's assent
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 6 Aug 2012.
- Background: PubMed 15339916Harry JB, Kobrinsky E, Abernethy DR, Soldatov NM. New short splice variants of the human cardiac Cavbeta2 subunit: redefining the major functional motifs implemented in modulation of the Cav1.2 channel. J Biol Chem. 2004 Nov 5;279(45):46367-72. doi: 10.1074/jbc.M409523200. Epub 2004 Aug 31.
- Background: PubMed 15671035Kobrinsky E, Tiwari S, Maltsev VA, Harry JB, Lakatta E, Abernethy DR, Soldatov NM. Differential role of the alpha1C subunit tails in regulation of the Cav1.2 channel by membrane potential, beta subunits, and Ca2+ ions. J Biol Chem. 2005 Apr 1;280(13):12474-85. doi: 10.1074/jbc.M412140200. Epub 2005 Jan 25.
- Background: PubMed 11861774Abernethy DR, Soldatov NM. Structure-functional diversity of human L-type Ca2+ channel: perspectives for new pharmacological targets. J Pharmacol Exp Ther. 2002 Mar;300(3):724-8. doi: 10.1124/jpet.300.3.724.
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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.
Samer Najjar, MD principal investigator
National Institute on Aging (NIA)
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 Atherosclerosis, run by National Institute on Aging (NIA) 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 2 inclusion and 3 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 6 Aug 2012. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251615, which also lists 3 linked publications.
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 6 Aug 2012.