RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease
Recruitment status was Recruiting
The objective of this study is to evaluate an antibiotic therapy called Rifalazil to determine its effect on hardening of the carotid arteries.
Coronary Artery Disease
Peripheral Vascular Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
|Official Title:||Randomized Evaluation of Short-Term Rifalazil Treatment on Carotid Atherosclerosis and Intima Media Thickness|
- To evaluate the treatment with Rifalazil versus placebo on high-resolution magnetic resonance imaging (MRI) determined by the normalized wall index (NWI) over a segment of the carotid artery at Day 180.
- NWI is defined as the wall area (WA) over the length of the arterial segment studied divided by the sum of the wall area plus the lumen area (LA) over the length of the arterial segment studied [NWI = WA / (WA + LA)].
- To evaluate the effect of rifalazil versus placebo on carotid intima media thickness (IMT), and carotid plaque composition by ultrasound and MRI and to determine the overall safety of a 12 week regimen of rifalazil administered once weekly.
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||September 2008|
To evaluate the effect of treatment with rifalazil versus placebo taken once weekly for 12 weeks on carotid atherosclerotic disease progression in patients who test positive for Chlamydia pneumoniae. Measurements of the carotid artery wall (intima-media thickness) and plaque characteristics will be evaluated with high-resolution magnetic resonance imaging (MRI) and carotid ultrasound. at Baseline and at 6,12 and 18 months following initiation of drug treatment in Chlamydia pneumoniae seropositive patients with a history of atherosclerotic disease. Biomarkers will be collected throughout the study. Safety will be evaluated by the collection and analysis of laboratory parameters, vital signs, electrocardiograms, physical examination and adverse events. Seventy two patients will be enrolled in this study. There will be a total of approximately 7-9 visits which will occur over an 18 month period.
|Contact: Emelia Klonowski Klonowskifirstname.lastname@example.org|
|United States, Michigan|
|Thoracic & Cardiovascular Healthcare Foundation||Recruiting|
|Lansing, Michigan, United States, 48910|
|United States, New York|
|St. Francis Hospital||Recruiting|
|Roslyn, New York, United States, 11576|
|Stony Brook University Medical Center||Recruiting|
|Stony Brook, New York, United States, 11794|
|United States, Texas|
|Baylor College of Medicine||Recruiting|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Swedish Medical Center||Recruiting|
|Seattle, Washington, United States, 98122|
|Robarts Research Institute||Recruiting|
|London, Ontario, Canada|