Carotid AtherosclerosisPhase 1NCT00001368
Potential Risk Factors for Stroke
A Phase 1 study testing cytokine and leukocyte activation profile in people with Carotid Atherosclerosis and Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Early studies have shown that the immune system may play a role in the development of strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can activate the immune system and increase the risk of developing hardening of the arteries (atherosclerosis) and damaged blood vessels. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Carotid Atherosclerosis, Cerebrovascular Accident, Diabetes Mellitus
- What is being tested?
- cytokine and leukocyte activation profile
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1993to Nov 2002
- Phase
- Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Male or female greater than 18 years of age.
Patient must have documented hypertension (diastolic BP greater than 90 mmHg or systolic BP greater than 140 mmHg) for greater than 1 year OR hypercholesterolemia (LDL greater than 160 or total Chol greater than 240 with a total cholesterol/HDL-Chol ratio more than 1.6 for greater that 1 year OR Diabetes (blood glucose greater than 150 mg/dl requiring oral antihyperglycemics or insulin dependent) for greater than 1 year OR any combination.
Subgroup eligibility for risk factors with cerebral ischemic events must meet criteria #2 plus documented stroke by physical exam and CT and/or MRI consistent with ischemic infarction or TIA witnessed and recorded by medical personnel.
Patient will be excluded if enrollment time is within 30 days of a stroke, myocardial infarction, or surgery. Patient may be enrolled after 30 days of the above events.
No patients on immunosuppressive therapy.
No patients who are unable to follow up for 1 year from the time of enrollment.
No stroke patients with an identifiable cardiac source (including atrial fibrillation, mural thrombus, valvular disease with vegetation).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Cytokine and Leukocyte Activation Profile as a Risk Factor for Cerebral Vascular Disease and Stroke
Early studies have shown that the immune system may play a role in the development of strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can activate the immune system and increase the risk of developing hardening of the arteries (atherosclerosis) and damaged blood vessels.
Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system, cytokines and leukocyte activation. Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke. Researchers will measure the immune system components at the beginning of the study, at six months, and at the one-year completion of the study.
Read more
The study will attempt to determine;
- If patients with risk factors for stroke have an increased activation of the immune system
II) If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms
III) If patients with increased activation of the immune system have accelerated hardening of the arteries (atherosclerosis)
Read the detailed description
Preliminary studies indicate that activation of the immune system by risk factors for stroke (hypertension, hypercholesterolemia, diabetes and age) increases the risk of atherosclerosis and the formation of intravascular thrombosis. By measuring the levels of cytokine and leukocyte activation in the stroke prone population and age matched controls without risk factors, an attempt will be made to characterize those factors which potentially increase the risk for carotid atherosclerosis and subsequent cerebral infarctions.
A total of one hundred twenty subjects with risk factors for stroke and forty controls will be enrolled over a two year period and followed for one year. All subjects will have blood drawn at the time of enrollment, at six months, and one year to measure cytokine levels (including Interleukin-I, Tumor Necrosis Factor-Alpha, Interleukin-8) and leukocyte activation/receptor (including Intercellular Adhesion Molecule-1 (ICAM-1), Endothelial Leukocyte Adhesion Molecule-1 (ELAM-1), V-Cell Adhesion Molecule (VCAM), and Macrophage Antigen-1). Carotid dopplers will be performed at the time of enrollment and at one year.
An analysis will be performed to: 1) determine if patients with risk factors for stroke have an increased activation of baseline cytokine levels and leukocytes, 2) determine if patients who have stroke risk factors and are symptomatic have an increased activation of cytokines and leukocyte vs. asymptomatic patients, and 3) determine if patients with increased cytokine/leukocyte activity have accelerated atherosclerosis of the carotid arteries.
- Conditions
- Carotid Atherosclerosis, Cerebrovascular Accident, Diabetes Mellitus, Hypercholesterolemia, Hypertension
- Being tested
- cytokine and leukocyte activation profile
- Keywords
- Cerebral Ischemia, Hypertension, Immune Response, Carotid Stenosis, Atherosclerosis
- Medical subject headings
- Carotid Artery Diseases, Stroke, Diabetes Mellitus, Hypercholesterolemia, Hypertension, Brain Ischemia, Carotid Stenosis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine and leukocyte activation profileProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startOct 1993
- Study completionNov 2002
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 Carotid 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001368
- Sponsor's protocol ID
- 930220
- Other IDs
- 93-N-0220
- Status last verified
- Nov 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
DeGraba TJ. The role of inflammation after acute stroke: utility of pursuing anti-adhesion molecule therapy. Neurology. 1998 Sep;51(3 Suppl 3):S62-8. doi: 10.1212/wnl.51.3_suppl_3.s62.
PubMed 9744839Siren AL, Heldman E, Doron D, Lysko PG, Yue TL, Liu Y, Feuerstein G, Hallenbeck JM. Release of proinflammatory and prothrombotic mediators in the brain and peripheral circulation in spontaneously hypertensive and normotensive Wistar-Kyoto rats. Stroke. 1992 Nov;23(11):1643-50; discussion 1650-1. doi: 10.1161/01.str.23.11.1643.
PubMed 1440713Loddick SA, Wong ML, Bongiorno PB, Gold PW, Licinio J, Rothwell NJ. Endogenous interleukin-1 receptor antagonist is neuroprotective. Biochem Biophys Res Commun. 1997 May 8;234(1):211-5. doi: 10.1006/bbrc.1997.6436.
PubMed 9168991
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine and Leukocyte Activation Profile as a Risk Factor for Cerebral Vascular Disease and Stroke
- ClinicalTrials.gov ID
- NCT00001368
- Acronym / sponsor ID
- 930220
- Conditions
- Carotid Atherosclerosis, Cerebrovascular Accident, Diabetes Mellitus, Hypercholesterolemia, Hypertension
- Keywords
- Cerebral Ischemia, Hypertension, Immune Response, Carotid Stenosis, Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 1993
- Study completion
- Nov 2002
- First posted
- 4 Nov 1999 (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.
Early studies have shown that the immune system may play a role in the development of strokes. Conditions such as high blood pressure, high cholesterol, diabetes, and old age can activate the immune system and increase the risk of developing hardening of the arteries (atherosclerosis) and damaged blood vessels.
Researchers will attempt to characterize factors that may contribute to atherosclerosis and stroke by measuring certain components of the immune system, cytokines and leukocyte activation. Measurements will be taken from patients that are considered to be stroke prone and from patients without risk factors for the development of stroke. Researchers will measure the immune system components at the beginning of the study, at six months, and at the one-year completion of the study.
The study will attempt to determine;
- If patients with risk factors for stroke have an increased activation of the immune system
II) If patients with risk factors for stroke that are symptomatic have higher levels of immune system activation compared to patients who do not have symptoms
III) If patients with increased activation of the immune system have accelerated hardening of the arteries (atherosclerosis)
Detailed description
Preliminary studies indicate that activation of the immune system by risk factors for stroke (hypertension, hypercholesterolemia, diabetes and age) increases the risk of atherosclerosis and the formation of intravascular thrombosis. By measuring the levels of cytokine and leukocyte activation in the stroke prone population and age matched controls without risk factors, an attempt will be made to characterize those factors which potentially increase the risk for carotid atherosclerosis and subsequent cerebral infarctions.
A total of one hundred twenty subjects with risk factors for stroke and forty controls will be enrolled over a two year period and followed for one year. All subjects will have blood drawn at the time of enrollment, at six months, and one year to measure cytokine levels (including Interleukin-I, Tumor Necrosis Factor-Alpha, Interleukin-8) and leukocyte activation/receptor (including Intercellular Adhesion Molecule-1 (ICAM-1), Endothelial Leukocyte Adhesion Molecule-1 (ELAM-1), V-Cell Adhesion Molecule (VCAM), and Macrophage Antigen-1). Carotid dopplers will be performed at the time of enrollment and at one year.
An analysis will be performed to: 1) determine if patients with risk factors for stroke have an increased activation of baseline cytokine levels and leukocytes, 2) determine if patients who have stroke risk factors and are symptomatic have an increased activation of cytokines and leukocyte vs. asymptomatic patients, and 3) determine if patients with increased cytokine/leukocyte activity have accelerated atherosclerosis of the carotid arteries.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytokine and leukocyte activation profile | Procedure or surgery | – |
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 4 Mar 2008.
- Background: PubMed 9744839DeGraba TJ. The role of inflammation after acute stroke: utility of pursuing anti-adhesion molecule therapy. Neurology. 1998 Sep;51(3 Suppl 3):S62-8. doi: 10.1212/wnl.51.3_suppl_3.s62.
- Background: PubMed 1440713Siren AL, Heldman E, Doron D, Lysko PG, Yue TL, Liu Y, Feuerstein G, Hallenbeck JM. Release of proinflammatory and prothrombotic mediators in the brain and peripheral circulation in spontaneously hypertensive and normotensive Wistar-Kyoto rats. Stroke. 1992 Nov;23(11):1643-50; discussion 1650-1. doi: 10.1161/01.str.23.11.1643.
- Background: PubMed 9168991Loddick SA, Wong ML, Bongiorno PB, Gold PW, Licinio J, Rothwell NJ. Endogenous interleukin-1 receptor antagonist is neuroprotective. Biochem Biophys Res Commun. 1997 May 8;234(1):211-5. doi: 10.1006/bbrc.1997.6436.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cytokine and leukocyte activation profile in people with Carotid Atherosclerosis and Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00001368, 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 4 Mar 2008.