1. Is there a decreased total peripheral resistance in supine patients with VVS after challenging them with nitroglycerine? 2. Is there a decreased total peripheral resistance in migraine after infusion of nitroglycerine? 3. What is the relation…
ID
Source
Brief title
Condition
- Headaches
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
At baseline, and during admission of NTG we will measure MAP, CO, TPR, HR, CO2
and TCD non-invasively .
Secondary outcome
none
Background summary
Migraine patients appear to have a larger and longer lasting decrease in total
peripheral resistance after receiving the vasodilator drug nitroglycerin (NTG),
given to induce a migraine attack.
NTG is given routinely to patients with presumed vasovagal syncope to induce
syncope, which effect is probably also caused by a decrease in total peripheral
resistance.
These disorders occur together more often than chance predicts, and might share
part of their pathophysiology. Until now, however, their vasodilator
responsivity has never been compared. We hope to obtain new information about
the pathophysiology of syncope and migraine, which might help to develop new
medication.
Study objective
1. Is there a decreased total peripheral resistance in supine patients with VVS
after challenging them with nitroglycerine?
2. Is there a decreased total peripheral resistance in migraine after infusion
of nitroglycerine?
3. What is the relation between difference in total peripheral resistance and
the time to the next migraine attack?
4. Do these findings explain the association between vasovagal syncope and
migraine?
5. Is the decrease in peripheral resistance reflected in an abnormal large
decrease of major leg veins?
Study design
Prospective, experimental study
Study burden and risks
Patients with migraine and syncope will be asked to participate by a
neurologist in our out-patient clinic. Healthy volunteers will be recruited
through public announcement. All subjects will receive a letter informing them
about the study. They will be invited to the out-patient clinic for the study.
There, they will first undergo a physical examination, and will then receive a
canula in the antecubital vein in the supine position. A Finometer continuous
blood pressure device (Finapres, Medical Systems) will be attached to the right
middle finger. Subjects will be given NTG 0,5 µg/kg/min intravenously for 20
minutes, conform the 'migraine provocation model' (Iversen HK 2001, Juhasz G
2003). Subjects will be informed about the possibility of having a migraine
attack after NTG, and will be instructed to stand up slowly after the
experiment to avoid syncope. Headache severity will be scored every hour during
the experiment using a visual rating scale, ranging from *0* (no headache) to
*10* (most severe headache). Afterwards subjects will be asked to fill in a
diary and report attacks of migraine within the next 24 hours. There will be no
personal benefit for patients.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
migraine:
-migraine without aura according to the IHS criteria;
-baseline attack frequency of 1 to 8 attacks per 2 months;
-moderate or severe headache during attacks;
-age between 18 and 55 years.
-female;syncope:
-diagnosis of vasovagal syncope confirmed by a tilt table test
- attack history must include at least 5 episodes of syncope or presyncope attacks
-age between 18 and 55 years
-female;migraine and syncope:
-migraine without aura according to the IHS criteria;
-baseline attack frequency of 1 to 8 attacks per 2 months;
-moderate or severe headache during attacks;
-age between 18 and 55 years.
-female
- diagnosis of vasovagal syncope confirmed by a tilt table test or
- attack history must include at least 5 episodes of syncope or presyncopal attacks ;heathy volunteers:
-age between 18-55 years
-female
Exclusion criteria
migraine:
-more than 10 days of headache per month;
-inability to differentiate between migraine and other forms of headache;
-pregnancy;
-current use of vasoactive medication;
-use of more than 4 units of caffeine per day during the last 14 days; ;syncope:
-inability to differentiate between vasovagal and other forms of Transient Loss of Consciousness
-pregnancy
-current use of vasoactive medication
-age beneath 18 or above 55 years
-use of more than 4 units of caffeine per day during the last 14 days;migraine en syncope:
-more than 10 days of headache per month;
-inability to differentiate between migraine and other forms of headache;
-pregnancy;
-current use of vasoactive medication;
-use of more than 4 units of caffeine per day during the last 14 days;
-inability to differentiate between vasovagal syncope and other forms of Transient Loss of Consciousness
-age beneath 18 or above 55 years;healthy volunteers:
-personal or first-degree-relative history of migraine or other primary headache syndrome, except infrequent episodic tension type headache;
- personal history of VVS or any first degree relatives with vasovagal syncope
-headache on > 2 days per month;
-pregnancy
-current use of vasoactive medication;
-use of more than 4 units of caffeine per day during the last 14 days
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44488.058.13 |