Atherosclerosis, Endothelial DysfunctionNCT00384761
Predictive Medicine Research
An observational study of Atherosclerosis, Endothelial Dysfunction, run by Emory University at 1 site in United States.
Trial summary
To establish normal values by age, race, and gender of novel markers of risk in healthy subjects necessary to predict precise risk of cardiovascular disease in an individual Read more about this study
- Who is it for?
- Ages 20 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Endothelial Dysfunction
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Oct 2010
- 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 20 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Individuals between ages 20-90
Who may be able to join
- Ages 20-90+
- Normal performance status
- LDL cholesterol level <120 mg/dl
- Fasting blood glucose <99 mg/dL
- Blood pressure <135 mmHg systolic and <85 mmHg diastolic
- Non-smoker for at least 5 years
- BMI >19 and <26; stable body weight
- Free of neurological and psychological (Axis I) disorders for at least three years.
Who cannot join
- Age <30
- Any oral antioxidants in the previous 2 weeks
- On lipid lowering medication in the past 8 weeks
- History of substance abuse
- Current cancer or history of cancer except basal cell cancer
- Any heart disease except for corrected congenital ht disease
Show all 23Show fewer
- History of neurological disease
- History of chronic GI disorders
- History of inflammatory joint disorders
- Known endocrine disorders
- History of Chronic Pulmonary diseases e.g. COPD
- Acute illness such as infection in the previous 4 weeks
- Creatinine > 2
- Liver enzymes >1.5X normal
- Anemia (Hemoglobin < 12.5) or chronic hematological disorder
- Physical limitation and sedentary status for any reason
- LDL cholesterol > 120
- Fasting Glucose > 99
- BP >135/85 on 3 repeated measures
- Current smoker or smoker in the last 5 years
- History of depression
- Inability to give informed consent
- For more information or patient referral call Johnson Pereira 404-275-0034, Rajinder Grover 404-686-7063, Muhammad Amer 404-805-4771 or Salman Sher 404-587-2667
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Medicine Research: Investigation of Predictors of Health, Sub-clinical and Clinical Organ System Disease
To establish normal values by age, race, and gender of novel markers of risk in healthy subjects necessary to predict precise risk of cardiovascular disease in an individual
Read the detailed description
Introduction
As a person ages their chance of developing certain diseases such as hardening of the arteries (atherosclerosis), diabetes, depression, osteoporosis and memory loss (Alzheimer's disease) increases. One of the theories that might explain why age increases the risk of developing these diseases involves a concept called oxidative stress. Oxidative stress is a process that occurs inside the cells in our body. All the cells in our body are constantly undergoing various biochemical reactions, which are important to the cell's life cycle. Byproducts of these biochemical reactions are molecules called free radicals or pro-oxidants. Pro-oxidants can be very damaging to the cell and lead to cell death. Cells also have molecules called antioxidants, which neutralize the pro-oxidants and protect the cell so it can continue functioning normally. Oxidative stress occurs when there is an imbalance in the pro-oxidants as compared with the antioxidants. Other studies have shown that diseases such as hardening of the arteries, depression, osteoporosis and Alzheimer's are associated with elevated levels of free radicals or pro-oxidants inside the cells. It is now possible to measure the levels of pro-oxidants in the cells using blood tests.
Objectives
The purpose of this study is to determine how reliable and reproducible these measurements are and also to define a "normal" value or range of values in healthy people. It is our hope that after we are able to define the normal range of values for oxidative stress we can then look at people with the aforementioned diseases and measure their levels of oxidative stress looking for a correlation between the two. If we can show a direct correlation between level of oxidative stress and these diseases we can begin trying to develop medicines that can target this area and hopefully prevent or lessen the degree of these diseases.
Tests and Evaluations
In this study we are looking for healthy participants age 30 and older who will undergo blood tests that will allow us to measure markers of oxidative stress. Participants will also undergo tests specifically designed to look for evidence of early multi-organ disease. These exams will include an evaluation of lung function (spirometry test), exercise capacity (using a stationary bike), bone density scan looking for osteoporosis, ultrasound of the artery of the neck (carotid) and artery of the arm (brachial), nerve conduction study, bio-impedance (Body fact composition) and several questionnaires to assess memory and mood. The participants require one screening visit and a follow up visit to undergo the tests.
- Conditions
- Atherosclerosis, Endothelial Dysfunction
- Medical subject headings
- Atherosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Stress
Measured: Cross Sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startMar 2006
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atherosclerosis, Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- The Robert W. Woodruff Foundation
- Responsible party
- Principal investigator, Arshed A. Quyyumi, Emory University
- Investigators
- Arshed Quyyumi, MD, Principal investigator, Emory HospitalMuhammad Amer, MD, Study director, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384761
- Sponsor's protocol ID
- IRB00024767a
- Other IDs
- PreMed 6012, 1190-2005
- Status last verified
- Nov 2013
- First submitted
- 3 Oct 2006
- Last updated
- 18 Nov 2013
- Results posted
- No
Publications
Al Mheid I, Patel R, Murrow J, Morris A, Rahman A, Fike L, Kavtaradze N, Uphoff I, Hooper C, Tangpricha V, Alexander RW, Brigham K, Quyyumi AA. Vitamin D status is associated with arterial stiffness and vascular dysfunction in healthy humans. J Am Coll Cardiol. 2011 Jul 5;58(2):186-92. doi: 10.1016/j.jacc.2011.02.051.
PubMed 21718915Patel RS, Al Mheid I, Morris AA, Ahmed Y, Kavtaradze N, Ali S, Dabhadkar K, Brigham K, Hooper WC, Alexander RW, Jones DP, Quyyumi AA. Oxidative stress is associated with impaired arterial elasticity. Atherosclerosis. 2011 Sep;218(1):90-5. doi: 10.1016/j.atherosclerosis.2011.04.033. Epub 2011 May 6.
PubMed 21605864
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Medicine Research: Investigation of Predictors of Health, Sub-clinical and Clinical Organ System Disease
- ClinicalTrials.gov ID
- NCT00384761
- Acronym / sponsor ID
- IRB00024767a
- Conditions
- Atherosclerosis, Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- The Robert W. Woodruff Foundation
- Study start
- Mar 2006
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Oct 2006 (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.
To establish normal values by age, race, and gender of novel markers of risk in healthy subjects necessary to predict precise risk of cardiovascular disease in an individual
Detailed description
Introduction
As a person ages their chance of developing certain diseases such as hardening of the arteries (atherosclerosis), diabetes, depression, osteoporosis and memory loss (Alzheimer's disease) increases. One of the theories that might explain why age increases the risk of developing these diseases involves a concept called oxidative stress. Oxidative stress is a process that occurs inside the cells in our body. All the cells in our body are constantly undergoing various biochemical reactions, which are important to the cell's life cycle. Byproducts of these biochemical reactions are molecules called free radicals or pro-oxidants. Pro-oxidants can be very damaging to the cell and lead to cell death. Cells also have molecules called antioxidants, which neutralize the pro-oxidants and protect the cell so it can continue functioning normally. Oxidative stress occurs when there is an imbalance in the pro-oxidants as compared with the antioxidants. Other studies have shown that diseases such as hardening of the arteries, depression, osteoporosis and Alzheimer's are associated with elevated levels of free radicals or pro-oxidants inside the cells. It is now possible to measure the levels of pro-oxidants in the cells using blood tests.
Objectives
The purpose of this study is to determine how reliable and reproducible these measurements are and also to define a "normal" value or range of values in healthy people. It is our hope that after we are able to define the normal range of values for oxidative stress we can then look at people with the aforementioned diseases and measure their levels of oxidative stress looking for a correlation between the two. If we can show a direct correlation between level of oxidative stress and these diseases we can begin trying to develop medicines that can target this area and hopefully prevent or lessen the degree of these diseases.
Tests and Evaluations
In this study we are looking for healthy participants age 30 and older who will undergo blood tests that will allow us to measure markers of oxidative stress. Participants will also undergo tests specifically designed to look for evidence of early multi-organ disease. These exams will include an evaluation of lung function (spirometry test), exercise capacity (using a stationary bike), bone density scan looking for osteoporosis, ultrasound of the artery of the neck (carotid) and artery of the arm (brachial), nerve conduction study, bio-impedance (Body fact composition) and several questionnaires to assess memory and mood. The participants require one screening visit and a follow up visit to undergo the tests.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Individuals between ages 20-90
Key inclusion criteria (8 listed)
- Ages 20-90+
- Normal performance status
- LDL cholesterol level <120 mg/dl
- Fasting blood glucose <99 mg/dL
- Blood pressure <135 mmHg systolic and <85 mmHg diastolic
Key exclusion criteria (23 listed)
- Age <30
- Any oral antioxidants in the previous 2 weeks
- On lipid lowering medication in the past 8 weeks
- History of substance abuse
- Current cancer or history of cancer except basal cell cancer
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
Oxidative Stress
Time frame: Cross Sectional
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 18 Nov 2013.
- Results publication: PubMed 21718915Al Mheid I, Patel R, Murrow J, Morris A, Rahman A, Fike L, Kavtaradze N, Uphoff I, Hooper C, Tangpricha V, Alexander RW, Brigham K, Quyyumi AA. Vitamin D status is associated with arterial stiffness and vascular dysfunction in healthy humans. J Am Coll Cardiol. 2011 Jul 5;58(2):186-92. doi: 10.1016/j.jacc.2011.02.051.
- Results publication: PubMed 21605864Patel RS, Al Mheid I, Morris AA, Ahmed Y, Kavtaradze N, Ali S, Dabhadkar K, Brigham K, Hooper WC, Alexander RW, Jones DP, Quyyumi AA. Oxidative stress is associated with impaired arterial elasticity. Atherosclerosis. 2011 Sep;218(1):90-5. doi: 10.1016/j.atherosclerosis.2011.04.033. Epub 2011 May 6.
Related trials for Atherosclerosis, Endothelial Dysfunction
Recruiting
New Heart Imaging Techniques to Evaluate Possible Heart Disease
Healthy, Obesity
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
Not yet recruitingObservational study
Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health
Atherosclerosis Cardiovascular Disease, Metabolic Syndrome
Active, not recruiting
Huangqi Gegen Decoction for Endothelial Function in Type 2 Diabetes at Very High ASCVD Risk
Type 2 Diabetes Mellitus, Endothelial Dysfunction
RecruitingPhase 1/2
TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
Atherosclerotic Cardiovascular Diseases, Endothelial Dysfunction
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.
Arshed Quyyumi, MD principal investigator
Emory Hospital
Muhammad Amer, MD study director
Emory University
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, Endothelial Dysfunction, run by Emory University 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 8 inclusion and 23 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 18 Nov 2013. 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?
Oxidative Stress (time frame: Cross Sectional). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00384761, which also lists 2 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 18 Nov 2013.