Welcome
Welcome to the
CFS Circulatory Study website. Researchers at the Center
for Pediatric Hypotension at New York Medical College
in Valhalla NY have received funding from the National Institutes of
Health (NIH) to study whether circulatory problems explain the symptoms
and signs of the chronic fatigue syndrome in teenagers..
The Principal
Investigator for this study is Julian M. Stewart MD, PhD,
Professor of Pediatrics and of Physiology
at New York Medical College.
What
comprises the study population?
What
is the hypothesis and importance of the study?
What
are the symptoms and findings in patients?
What
is the goal of the study?
What
your own doctor can do to help diagnose CFS.
How
do I know if I知 eligible to be in this study?
Who
pays for the exams, testing, and travel?
How
can I get a screening application for this study?
If
I decide to participate what does the study entail?
What
comprises the study population?
We are seeking
patients aged 13-19 years old patients with chronic fatigue syndrome (CFS)
who may benefit from an investigation for abnormalities of blood
pressure, heart rate and blood flow. the hypothesis of circulatory
dysfunction in CFS. Recent investigations indicate that most teenagers
with CFS have a form of chronic orthostatic intolerance (the inability
to remain upright without symptoms) called the postural tachycardia
syndrome (POTS) which impairs blood flow and heart rate, and sometimes
causes a fall in blood pressure. Fainting is uncommon. These patients
have symptoms of chronic orthostatic intolerance including dizziness,
fatigue, nausea, headache, pallor, and neurocognitive loss (difficulty
thinking) which overlap with the case definition of CFS.
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What
is the hypothesis and importance
We are
investigating the hypothesis that a specific form of circulatory
dysfunction produces the symptoms of CFS in teenagers. Recent
investigations indicate that many teenagers with CFS have a form
of chronic orthostatic intolerance (the inability to remain upright
without symptoms) called the postural tachycardia syndrome (POTS) which
impairs blood flow and heart rate, and sometimes causes a fall in blood
pressure. Results from our laboratory and other laboratories suggest
that low blood volume or a defect in the contraction of blood vessels
(vasoconstriction) causing a blood to accumulate inappropriately
accounts for symptoms and findings in POTS. Blood vessel findings are
even present lying down but become more evident when upright. Defects
may vary from patient to patient and changes in limb color (e.g. purple
discoloration) can occur when upright.
What
are the symptoms of POTS
Fainting is uncommon. Symptoms of
POTS and chronic orthostatic intolerance including dizziness, fatigue,
nausea and abdominal pain, headache, pallor, and neurocognitive loss
(difficulty thinking), shakiness and exercise intolerance which overlap
with the case definition of CFS.
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What
is the goal of the study
Our
study will determine how often POTS occurs in CFS, and the mechanism(s)
of POTS in individual patients. Specific causes for POTS may vary from
patient to patient. Patients will be compared to healthy control
subjects. We will also test a medication used for treating POTS which
may help teenagers with CFS.
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What
can your own doctor do
Your doctor can
rule out other illnesses such as infectious and inflammatory conditions
which can produce similar symptoms. For example, most blood tests will
be performed by your own physician. However, the tests we will be
performing are not ordinarily available to your doctor. They are,
however, all approved ways of measuring how blood vessels work. POTS can
be treated by a combination of lifestyle adjustments and medication
which your doctor can administer. The tests performed during the study
may help us determine what treatment is best for you. We will provide
you and your doctor with test results and treatment information.
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How
do I know if I知 eligible to be in this study?
Even though the
study focuses on CFS patients with circulatory dysfunction, all CFS
patients should enroll. At this time we cannot predict who has
circulatory dysfunction or if POTS is the only form of orthostatic
intolerance in teenagers with CFS. Therefore all patients who fulfill
the criteria for CFS (using the 1994 Centers for Disease Control
definition) and are between 13 and 19 years old can enroll.
The
diagnosis of CFS should be made by a doctor, either your own physician
or through contact with our center.
Exclusion:The
criteria for initial exclusion are adapted from the CDC
and include: 1) an active medical condition that may explain the
diagnosis; 2) a previous medical condition with undocumented resolution;
3) a past or current major psychiatric disorder; 4) a history of alcohol
or substance abuse within 2 years before the onset of the chronic
fatigue.
Inclusion:
The criteria for
initial inclusion are adapted from the CDC:13
and 19 years old adolescents
who have persistent or relapsing chronic fatigue of new or definite
onset; and the concurrent occurrence of four or more of the following
symptoms that have persisted or recurred during at least 6 consecutive
months and have not predated the fatigue:
1) impairment
in memory or concentration severe enough to cause substantial reduction
of previous levels of educational, social or personal activities. In
adolescents this may be most notable by a decline in academic
performance and school attendance;
2) muscle pain or multi joint pain;
3) headaches of a new type, pattern, or severity;
4) unrefreshing sleep; and
5) post-exertional malaise lasting more than 24
hours.
Sore
throat and swollen glands are unreliable criteria during adolescence
.
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Who
pays for the exams, or testing?
There is no
charge to you for any of the the testing or testing medication. We will
pay each participant who $200 as a token of appreciation for their time.
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How
can I get a screening application for this study?
You can click on
the Screening icon, and download
and print out the application and mail it to us. The mailing address is
on the last page of the form. Alternatively you can email the
application to stewart@nymc.edu or you can also fax us the application at
914-594-4513. Or, you can call us at 914-594-4370, leave your name and
address on the voicemail and we値l mail you an application.
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What
happens if I知 eligible to be in the study and decide to
participate?
If you would like
to take part in this study, the study nurse will contact you to go over
questionnaire material and discuss arranging for the study. The study
nurse will review the consent form with you and we will also review the
consent and any questions you may have when you arrive for the study.
You and your parents should understand the study, and its risks and
benefits. You can click on the icon for Consent Form to read about our
study.
We will make an appointment to come to
The Center for Pediatric Hypotension for your study
visit.
You値l arrive at 9:00-10 AM on the day of your
appointment. We ask that you not eat or drink anything after 8 AM that
morning. Please wear comfortable clothing and bring along a pair of
shorts and a short sleeve shirt.
We will meet you
at the Bradhurst Building and take you to the laboratory area. Here the
you will meet Dr. Jose Munoz and Dr. Julian Stewart who, along with the nurse, will review the study with you,
and answer any questions you may have. After obtaining your or your
parents informed consent and informed assent if appropriate, you値l
answer a few questions, have a brief physical examination, and be
taken to the laboratory area.
Patients will
undergo studies of blood flow while lying down and also when gradually
tilted upright. We will assess arm and leg blood vessel properties.
Simple tests of how the nervous system adjusts to changes in circulation
will also be performed. We will also measure blood hormone levels and
blood volume using a dye technique. There will be no invasive aspects to
our tests except for the intravenous line to measure hormone levels and
measure blood volume.
Over a 5 week
period CFS patients will receive an FDA approved medication called
proamatine (midodrine) which contracts blood vessels or a placebo (like
a sugar pill) with no blood vessel properties for 2 weeks and then will
have limited retesting. After a week to allow the drug to wear off, each
patient will receive the other type of pill (placebo or drug) for 2 more
weeks and be retested again. Neither patients nor investigators will
know which order patients receive the pills until the study is over. We
have already tested a similar intravenous drug called phenylephrine in a
pilot group of patients which seems to benefit many of them without
causing increased symptoms.
We believe that this study will help to determine the specific
cause of POTS in CFS and will point towards improved medical therapy for
teenage patients.
We expect that your visit will take about 4
hours total with the laboratory part comprising 3 hours.
If you have
further questions about the study, please feel free to call:
914-594-4370 for
more information.
or Email at stewart@nymc.edu
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