|First Submitted Date ICMJE||June 28, 2000|
|First Posted Date ICMJE||June 29, 2000|
|Last Update Posted Date||March 4, 2008|
|Start Date ICMJE||June 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00005928 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of Angiotensin-Converting Enzyme Inhibitor (Ramipril) Therapy on Blood Vessel Inflammation|
|Official Title ICMJE||Effects of Angiotensin Converting Enzyme Inhibitor Therapy on Vascular Inflammation and Compliance|
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:
|Detailed Description||Vascular inflammation plays a major role in the progression and clinical expression of atherosclerosis and may contribute to stiffening of arteries that increases the risk of myocardial infarction and stroke. Therapies that reduce vascular inflammation may reduce cardiovascular events. Angiotensin converting enzyme (ACE) inhibitor therapy reduces cardiovascular events in patients with coronary artery disease (CAD), potentially by reducing vascular oxidant stress and activation of genes that encode protein mediators of inflammation. However, we found that ACE inhibitor therapy in patients with CAD had no overall significant effect on serum levels of cell adhesion molecules VCAM-1, ICAM-1, and E-selectin (surrogate markers of vascular inflammation), although some patients showed a reduction in levels, suggesting either that these surrogate markers of vascular inflammation may not accurately reflect reduction in vascular inflammation, or that only a subset of patients have biological responses that might reduce their cardiovascular risk. The purposes of this protocol are to determine 1) the effect of ACE inhibitor therapy on vascular inflammation in patients with coronary artery disease as assessed by MRI of the carotid arteries, and 2) whether serum markers of inflammation correlate with reduced vascular inflammation and thus may be suitable surrogates for determining success of ACE inhibitor therapy.|
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Ramipril|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Estimated Completion Date||February 2002|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
All volunteer subjects must be between 40 and 75 years of age with documented CAD, and must have provided informed, written consent for participation in this study.
Ability to comprehend or willingness to sign the consent form.
No pregnant women or women with child-bearing potential not on effective contraception.
No ACE inhibitor therapy within 6 months.
No renal insufficiency (creatinine greater than 2.0 mg/dl).
Blood pressure must not be higher than 140/90 on current medical therapy.
No history of involuntary motion disorder.
Specific MRI exclusion criteria (i.e. pacemaker, cochlear implants, AICD, internal infusion pump, metal implants or clips in field of view).
No systemic inflammatory disorder (e.g, rheumatoid arthritis, periarteritis nodosa, systemic lupus erythromatosus, temporal arteritis).
No need for chronic NSAID therapy.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00005928|
|Other Study ID Numbers ICMJE||000162
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2002|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP