Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation
Status:
Completed
Trial end date:
2002-02-01
Target enrollment:
Participant gender:
Summary
This study will determine the effects of angiotensin-converting enzyme (ACE) inhibitor (trade
name Ramipril) therapy on inflammation and stiffness of artery walls. These are two risk
factors for developing atherosclerosis-deposits of fatty substances called plaques that can
block the blood vessel, causing a heart attack or stroke. Studies of patients with coronary
artery disease suggest that ACE inhibitor therapy reduces the risk of heart attack and heart
failure. This study will examine the effects of this treatment on the artery walls and on
levels of substances in the blood that indicate blood vessel inflammation.
Patients between 40 and 75 years old with coronary artery disease caused by atherosclerosis
may be eligible for this study. Candidates will be screened with a medical history,
cardiovascular (heart and blood vessel) examination, electrocardiogram and blood tests. Those
enrolled will be randomly assigned to take either an ACE inhibitor pill or a placebo
(look-alike pill with no medicine) once a day for 3 months. No pills will be taken for the
next month, and then participants will take the alternate pill for the next 3 months. That
is, those who took ACE inhibitor for the first 3-month period will take placebo for the
second 3-month period and vice versa. Blood pressures will be taken at the NIH Clinical
Center or by the patient's physician at the end of the first and second weeks of the study.
At the end of 3 weeks, patients will return to the Clinical Center for a blood draw of 6 cc
(1/2 teaspoon) to assess kidney function. In addition, at the end of each 3-month study
period, patients will undergo the following procedures at the Clinical Center:
1. Fasting blood draw of 60 cc (2 ounces) to measure electrolytes (e.g., sodium and
potassium) and blood markers for inflammation
2. Ultrasound (use of sound waves to create pictures) study of the carotid arteries
(arteries in the neck leading to the brain)-An ultrasound probe is applied gently on the
neck, and ultrasound pictures of the right and left carotid arteries are recorded on
tape. Heart activity and blood pressure are monitored during the procedure with an
electrocardiogram and blood pressure cuff.
3. Magnetic resonance imaging (MRI) of the carotid arteries-The patient lies on a table in
a narrow cylinder (the MRI machine) containing a magnetic field. A flexible padded
sensor called a MRI coil is placed over the neck area. Earplugs are placed in the ear to
muffle the loud thumping sounds the machine makes when the magnetic fields are switched.
During the second half of the exam, a contrast agent (gadolinium) is injected through an
intravenous catheter (flexible tube placed in a vein) to brighten the images. The heart
is monitored during the procedure with an electrocardiogram.