HealthyPhase 1NCT00001622
Study of the Response of Human Small Blood Vessels
A Phase 1 study testing investigate the relationship between in vivo and in vitro vascular responses in people with Healthy and Hypercholesterolemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
A layer of cells called the endothelium line the walls of blood vessels. These cells produce substances that control the tone of blood vessels and thus control blood flow through the vessel. One of the substances produced involved in the control of blood vessel function is nitric oxide. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hypercholesterolemia, Hypertension
- What is being tested?
- investigate the relationship between in vivo and in vitro vascular responses
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Mar 2001
- 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
Patients (men and nonpregnant women) with systemic hypertension, patients with hypercholesterolemia, and normal volunteers.
All blood pressure recordings must be consistently elevated.
No renovascular hypertension or other etiologies for elevated blood pressure.
No definite evidence of accelerated or malignant hypertension (diastolic pressures above 115 mmHg, with associated encephalopathic changes, papilledema, progressive renal failure, or congestive heart failure), or serious intercurrent illness.
Patients in whom withdrawal of antihypertensive medications is considered hazardous are ineligible.
Patients in whom the blood pressure remains at normal levels 2 weeks after withdrawal of antihypertensive treatment will be closely monitored until they become hypertensive, at which time they will undergo the study. Patients in whom blood pressure does not increase after 2 months of discontinuation of therapy will be excluded from the study.
Patients with coexistent hypertension and hypercholesterolemia are ineligible.
Normal volunteers who are not taking any kind of medication are eligible.
No history of diabetes, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
No history of keloid formation.
All patients must be capable of giving informed consent for all procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Study of the Relation Between In Vivo and In Vitro Response of Human Small Vessels
A layer of cells called the endothelium line the walls of blood vessels. These cells produce substances that control the tone of blood vessels and thus control blood flow through the vessel. One of the substances produced involved in the control of blood vessel function is nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels.
Researchers have been interested in the function of the endothelium in patients with high blood pressure (essential hypertension) and patients with high cholesterol (hypercholesterolemia).
Read more
After conducting studies on the endothelium and nitric oxide, researchers have found that the endothelium is indeed functioning abnormally in patients with high blood pressure and high cholesterol. In addition, researchers have determined that the dysfunction is a result of abnormalities in the nitric oxide (NO) system.
In this study researchers plan to investigate the relationship between blood vessel responses in real-life settings versus laboratory settings in normal volunteers, patients with high blood pressure, and patients with high cholesterol.
Read the detailed description
Over the last ten years, we have been interested in the investigation of endothelial function in patients with essential hypertension and patients with hypercholesterolemia. We have performed intra-arterial infusion of endothelium-dependent and endothelium-independent drugs into the brachial artery with noninvasive measurement of the response of the forearm vasculature by means of strain gauge plethysmography. Those studies have allowed us to: a) demonstrate the presence of endothelial dysfunction in patients with essential hypertension and in patients with hypercholesterolemia; and b) identify an abnormality in the endothelium-derived nitric oxide system that is responsible for endothelial dysfunction in these patients. Further studies to more precisely determine the intracellular processes that mediate this abnormality in endothelial function in these patients are limited by the inherent shortcomings of the in vivo technique. An alternative possibility is the study of human small vessels in vitro; however, the relationship between in vivo and in vitro vascular responses to endothelium-dependent and -independent agonists has not been established. In the present study, we propose to investigate this relationship in normal volunteers, patients with essential hypertension, and patients with hypercholesterolemia.
- Conditions
- Healthy, Hypercholesterolemia, Hypertension
- Being tested
- investigate the relationship between in vivo and in vitro vascular responses
- Keywords
- Endothelium, Hypercholesterolemia, Hypertension, Microvessels, Vasodilation, Normal Volunteer
- Medical subject headings
- Hypercholesterolemia, Hypertension, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigate the relationship between in vivo and in vitro vascular responsesProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1997
- Study completionMar 2001
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 HealthyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 87 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001622
- Sponsor's protocol ID
- 970098
- Other IDs
- 97-H-0098
- Status last verified
- Jan 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Furchgott RF. Role of endothelium in responses of vascular smooth muscle. Circ Res. 1983 Nov;53(5):557-73. doi: 10.1161/01.res.53.5.557. No abstract available.
PubMed 6313250Falloon BJ, Heagerty AM. In vitro perfusion studies of human resistance artery function in essential hypertension. Hypertension. 1994 Jul;24(1):16-23. doi: 10.1161/01.hyp.24.1.16.
PubMed 8021003Goode GK, Heagerty AM. In vitro responses of human peripheral small arteries in hypercholesterolemia and effects of therapy. Circulation. 1995 Jun 15;91(12):2898-903. doi: 10.1161/01.cir.91.12.2898.
PubMed 7796498
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
- Study of the Relation Between In Vivo and In Vitro Response of Human Small Vessels
- ClinicalTrials.gov ID
- NCT00001622
- Acronym / sponsor ID
- 970098
- Conditions
- Healthy, Hypercholesterolemia, Hypertension
- Keywords
- Endothelium, Hypercholesterolemia, Hypertension, Microvessels, Vasodilation, Normal Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 1997
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (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.
A layer of cells called the endothelium line the walls of blood vessels. These cells produce substances that control the tone of blood vessels and thus control blood flow through the vessel. One of the substances produced involved in the control of blood vessel function is nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels.
Researchers have been interested in the function of the endothelium in patients with high blood pressure (essential hypertension) and patients with high cholesterol (hypercholesterolemia).
After conducting studies on the endothelium and nitric oxide, researchers have found that the endothelium is indeed functioning abnormally in patients with high blood pressure and high cholesterol. In addition, researchers have determined that the dysfunction is a result of abnormalities in the nitric oxide (NO) system.
In this study researchers plan to investigate the relationship between blood vessel responses in real-life settings versus laboratory settings in normal volunteers, patients with high blood pressure, and patients with high cholesterol.
Detailed description
Over the last ten years, we have been interested in the investigation of endothelial function in patients with essential hypertension and patients with hypercholesterolemia. We have performed intra-arterial infusion of endothelium-dependent and endothelium-independent drugs into the brachial artery with noninvasive measurement of the response of the forearm vasculature by means of strain gauge plethysmography. Those studies have allowed us to: a) demonstrate the presence of endothelial dysfunction in patients with essential hypertension and in patients with hypercholesterolemia; and b) identify an abnormality in the endothelium-derived nitric oxide system that is responsible for endothelial dysfunction in these patients. Further studies to more precisely determine the intracellular processes that mediate this abnormality in endothelial function in these patients are limited by the inherent shortcomings of the in vivo technique. An alternative possibility is the study of human small vessels in vitro; however, the relationship between in vivo and in vitro vascular responses to endothelium-dependent and -independent agonists has not been established. In the present study, we propose to investigate this relationship in normal volunteers, patients with essential hypertension, and patients with hypercholesterolemia.
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 |
|---|---|---|
| investigate the relationship between in vivo and in vitro vascular responses | 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 6313250Furchgott RF. Role of endothelium in responses of vascular smooth muscle. Circ Res. 1983 Nov;53(5):557-73. doi: 10.1161/01.res.53.5.557. No abstract available.
- Background: PubMed 8021003Falloon BJ, Heagerty AM. In vitro perfusion studies of human resistance artery function in essential hypertension. Hypertension. 1994 Jul;24(1):16-23. doi: 10.1161/01.hyp.24.1.16.
- Background: PubMed 7796498Goode GK, Heagerty AM. In vitro responses of human peripheral small arteries in hypercholesterolemia and effects of therapy. Circulation. 1995 Jun 15;91(12):2898-903. doi: 10.1161/01.cir.91.12.2898.
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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 investigate the relationship between in vivo and in vitro vascular responses in people with Healthy and Hypercholesterolemia, run by National Heart, Lung, and Blood Institute (NHLBI) 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 NCT00001622, 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.