HealthyNCT00363792
Effect of GTN and Diamox Measured by BOLD-Response.
A study testing Glyceryl trinitrate, azetazolamide in people with Healthy, run by Danish Headache Center at 1 site in Denmark.
Trial summary
In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are: Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation. Changes in the diameter of a. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Glyceryl trinitrate, azetazolamide
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Start not givento May 2007
- Phase
- Interventional
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
- age 18-55 years
- weight 50-100 kg
Who cannot join
- Tension type headache more the once per month.
- other types of headache
- Daily use of medication other the birthcontrol pills.
- Pregnant or lactating women.
- headache on the examination date.
- contraindications to MRI-scan.
Show all 9Show fewer
- hypotension or hypertension.
- mental illness og substance abuse.
- other significant conditions determined by the examining doctor.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Glostrup Municipality, 2770
Mohammad Sohail Asghar, MD, +4543232161, asgsoh01@glostruphosp.kbhamt.dk
Mohammad Sohail Asghar, MD
About this study
Official title: The Effect of Glyceryl Trinitrate and Diamox on Blood-Oxygenation-Level-Dependent.Signal (BOLD-Signal) and Cerebral Haemodynamics With the Use of a 3-Tesla MRI-Scan.
In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are:
- Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
- Changes in the diameter of a. cerebri media.
- Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.
Read the detailed description
Experimental headache models give a unike opportunity to study pathophysiological mechanisms of prim. headache types such as migraine. Previous studies have used different methods that have had limitations and none of them have had the opportunity to study neuronal activation. But that is possible with the application of functional magnetic resonance (fMRI).
Before we apply fMRI to our experimental headache models it is needed to determine how the BOLD response is influenced and changed by the infusion of different drugs such as the NO donor Glyceryl Trinitrate (GTN) and Diamox (acetazolamide). It is known that GTN causes dilation of the cerebral arteries without having any effect on the regional cerebral blood flow. It is not known what effect GTN has on the BOLD response. Diamox (azetazolamide) increases the CBF but it is uncertain what effect the drug has on the BOLD response. Previous studies disagree gravely on this point.
In this study we will be giving infusion of GTN and Diamox in healty subjects to determine:
- Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
- Changes in the diameter of a. cerebri media.
- Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) methode.
For the study we will be using a 3-Tesla MRI-scan.
- Conditions
- Healthy
- Being tested
- Glyceryl trinitrate, azetazolamide
- Keywords
- Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glyceryl trinitrate, azetazolamideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in BOLD response
Changes in a. cerebri media diameter
Changes in CBF
Secondary outcomes (1)
headache score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2006 (estimated)
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 12 participants
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Investigators
- Messoud Ashina, MD, Phd,, Study chair, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00363792
- Sponsor's protocol ID
- KA-20060085
- Status last verified
- Aug 2006
- First submitted
- 11 Aug 2006
- Last updated
- 15 Aug 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Glyceryl Trinitrate and Diamox on Blood-Oxygenation-Level-Dependent.Signal (BOLD-Signal) and Cerebral Haemodynamics With the Use of a 3-Tesla MRI-Scan.
- ClinicalTrials.gov ID
- NCT00363792
- Acronym / sponsor ID
- KA-20060085
- Conditions
- Healthy
- Keywords
- Healthy subjects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study completion
- May 2007
- First posted
- 15 Aug 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.
In healthy subjects different cerebral haemodynamic values wished to be determined after infusion of the NO donor Glyceryl trinitrate (GTN) and Diamox. The different values we wish to determine are:
- Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
- Changes in the diameter of a. cerebri media.
- Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) method.
Detailed description
Experimental headache models give a unike opportunity to study pathophysiological mechanisms of prim. headache types such as migraine. Previous studies have used different methods that have had limitations and none of them have had the opportunity to study neuronal activation. But that is possible with the application of functional magnetic resonance (fMRI).
Before we apply fMRI to our experimental headache models it is needed to determine how the BOLD response is influenced and changed by the infusion of different drugs such as the NO donor Glyceryl Trinitrate (GTN) and Diamox (acetazolamide). It is known that GTN causes dilation of the cerebral arteries without having any effect on the regional cerebral blood flow. It is not known what effect GTN has on the BOLD response. Diamox (azetazolamide) increases the CBF but it is uncertain what effect the drug has on the BOLD response. Previous studies disagree gravely on this point.
In this study we will be giving infusion of GTN and Diamox in healty subjects to determine:
- Blood-oxygenation-level-Dependent-signal (BOLD-signal) after visual stimulation.
- Changes in the diameter of a. cerebri media.
- Changes in the regional and global cerebral blodd flow (CBF) with the help of the arterial Spin labeling (ASL) methode.
For the study we will be using a 3-Tesla MRI-scan.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy subjects
- age 18-55 years
- weight 50-100 kg
Key exclusion criteria (9 listed)
- Tension type headache more the once per month.
- other types of headache
- Daily use of medication other the birthcontrol pills.
- Pregnant or lactating women.
- headache on the examination date.
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 |
|---|---|---|
| Glyceryl trinitrate, azetazolamide | Drug | – |
Primary outcome
Changes in BOLD response
Changes in a. cerebri media diameter
Changes in CBF
1 secondary outcome
headache score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2006.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Messoud Ashina, MD, Phd, study chair
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glyceryl trinitrate, azetazolamide in people with Healthy, run by Danish Headache Center at 1 site in Denmark.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Aug 2006. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Sohail Asghar, MD (+4543232161, asgsoh01@glostruphosp.kbhamt.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in BOLD response. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 15 Aug 2006.