Hepatitis C Treatment and Atherosclerosis
关键词
抽象
描述
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.
日期
| 最后验证: | 03/23/2015 |
| 首次提交: | 04/14/2008 |
| 提交的预估入学人数: | 04/14/2008 |
| 首次发布: | 04/15/2008 |
| 上次提交的更新: | 12/10/2019 |
| 最近更新发布: | 12/11/2019 |
| 实际学习开始日期: | 04/07/2008 |
| 预计完成日期: | 03/23/2015 |
状况或疾病
相
资格标准
| 有资格学习的年龄 | 30 Years 至 30 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | - INCLUSION CRITERIA: Age equal to or greater than 30 years, male or female Written informed consent All ethnicities Viral hepatitis status: - Cases: - History of chronic hepatitis C defined by past positivity for serum HCV-RNA, HCV antibody and elevated serum alanine or aspartate aminotransferase levels for at least 6 months before start of treatment - Genotype 1, 2 or 3 - Absence of detectable serum HCV-RNA by PCR on screening visit and on a previous test, at least 3 months apart. Both tests have to be performed at least 24 weeks after cessation of therapy - Past treatment with interferon alfa (standard or pegylated) for at least 12 weeks - At least 12 months after end of interferon treatment - Normal liver enzymes on screening visit - Genotype 1 controls: - Detectable serum HCV-RNA on screening visit - Past treatment with interferon alfa (standard or pegylated) for at least 12 weeks - At least 12 months after end of interferon treatment - Age (difference less than or equal to 3 years), sex and race-matched with genotype 1 cases - Genotype 2 and 3 controls: - Detectable serum HCV-RNA on screening visit - If previously treated with interferon alfa (standard or pegylated) - at least 12 months elapsed from the end of treatment - Age (difference less than or equal to 3 years), sex, race and genotype-matched with genotype 2 and 3 cases EXCLUSION CRITERIA: Pregnancy or lactation History of clinical atherosclerotic disease manifest as: - Ischemic cerebrovascular accident (CVA), transient ischemic accident (TIA) or radiological evidence of stroke. - Proven coronary artery disease history of myocardial infarction, need for coronary angioplasty or coronary artery bypass graft, anginal syndrome with confirmatory stress test or cardiac imaging. - Symptomatic peripheral vascular disease, history of angioplasty or surgical bypass. - History of carotid artery surgery or angioplasty - Patients with overt atherosclerotic disease can be included if the first manifestation of that disease appeared at least 3 years after cessation of interferon treatment. Control patients who were never treated in the past will not be included if there is an overt manifestation of atherosclerosis. Diabetes mellitus unless fasting blood sugar can be maintained within normal limits and HBA1C less than 7 without the need for pharmacologic intervention Hypertension unless blood pressures can be maintained for greater than 6 months within normal limits without the need for pharmacologic intervention Current treatment with cholesterol lowering medications Chronic renal failure (creatinine clearance less than 50 ml) Known HIV infection HCV genotype 4, 5, 6 or mixed infection. Other causes of liver disease apart from hepatitis C (hepatitis B, alcoholic liver disease, NASH, autoimmune hepatitis, PBC etc.). Bland, non-alcoholic hepatic steatosis will not constitute an exclusion criterion History of trauma to the neck, surgery or deformity precluding sonographic visualization of the carotid arteries Inability to sign or understand the informed consent form A contraindication or unwillingness to undergo the coronary calcium score CT scan will not be an exclusion criterion, as this is not a primary end-point, as long as the participant is willing to undergo an IMT measurement. |
结果
主要结果指标
1. Intima-media thickness [undefined]
次要成果指标
1. Coronary calcium score, Framingham score [undefined]
