Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-02 @ 8:43 PM
Study NCT ID:
NCT00659256
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatitis C Treatment and Atherosclerosis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
Hepatitis C Eradication and Progression of Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2015-03-24
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the effects of treatment for hepatitis C on atherosclerosis, or hardening of the arteries. Hepatitis C is a disease of the liver caused by a virus that can cause permanent damage to that organ. Treatment can clear the virus in at least half of patients and reduce the risk of serious complications of the disease. Atherosclerosis is an accumulation of cholesterol and fat in the arteries that can narrow blood vessels, leading to chest pain, heart attack or stroke.
Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels. Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences. This study will determine what effect hepatitis C treatment has on the rate of atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.
Patients 30 years of age and older with current or past infection with hepatitis C may be eligible for this study. Participants undergo the following tests and procedures:
* Questionnaires regarding risk factors for heart disease and stroke
* Measurements of blood pressure, heart rate, weight, height, waist and hips
* Blood tests
* CT scans and ultrasound tests to measure the degree of blood vessel hardening and narrowing in the heart and neck region
Because the liver controls cholesterol and fat levels in the blood, hepatitis C infection may be a risk factor for atherosclerosis by increasing cholesterol and fat in blood vessels. Treatment of the hepatitis C may reduce the risk of atherosclerosis and its consequences. This study will determine what effect hepatitis C treatment has on the rate of atherosclerosis and narrowing of blood vessels and on the risk of heart attack or stroke.
Patients 30 years of age and older with current or past infection with hepatitis C may be eligible for this study. Participants undergo the following tests and procedures:
* Questionnaires regarding risk factors for heart disease and stroke
* Measurements of blood pressure, heart rate, weight, height, waist and hips
* Blood tests
* CT scans and ultrasound tests to measure the degree of blood vessel hardening and narrowing in the heart and neck region
Detailed Description:
Hepatitis C virus (HCV) infection is associated with changes in lipid metabolism in the liver and the peripheral blood. Patients with chronic hepatitis C infection tend to have low levels of cholesterol and LDL-cholesterol. These levels increase in many patients after treatment and successful eradication of the virus. However, it is not known whether this increase is associated with increased cardiovascular risk and thus may increase their risk for atherosclerotic disease. To determine whether eradication of HCV affects atherosclerosis progression, we propose to examine up to 200 patients with chronic hepatitis C for markers of atherosclerosis and the risk of its complications. Up to 100 patients who have cleared HCV and recovered will be matched and compared to patients who failed to respond and continue to have chronic hepatitis C. The atherosclerosis assessment will include careful history for cardiovascular risk factors, a battery of blood tests for lipid levels and relevant biomarkers followed by specialized imaging tests of the carotid and coronary arteries, including ultrasound imaging of intima-media thickness of the carotid arteries and computerized axial tomography of the heart and coronary arteries. The primary end point in the assessment will be differences in maximal carotid intima media thickness and secondary end points will include differences in coronary artery calcium score, Framingham risk scores and other measurements or atherosclerosis. This cross-sectional study will set the stage for a more formal prospective assessment of cardiovascular risk factors and evidence of coronary and cerebrovascular disease among patients being treated with antiviral agents.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 08-DK-0106 | None | None | View |