Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005547
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Infection and Cardiovascular Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-01
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:
To investigate the role of chronic infection as a risk factor for vascular disease in a study of Native Americans The primary focus is on the two most common agents Chlamydia pneumoniae and cytomegalovirus with a secondary emphasis on Helicobacter pylori
Detailed Description:
BACKGROUND
Recent studies have associated evidence of Chlamydia pneumoniae infection with coronary and carotid atherosclerosis and evidence of increased infection with cytomegalovirus CMV in patients developing restenosis or with atherosclerosis Several other common pathogens have been less consistently associated with atherosclerosis Altered parameters of inflammation and hemostasis have been identified as prognostic factors of myocardial infarction and have been linked as possible pathogenetic mechanisms Recent studies have indicated that peripheral blood mononuclear cells PBMC from patients with coronary artery disease frequently include Chlamydia pneumoniae DNA and stimulation of PBMCs can reflect an unsuccessful host cellular immune response to CMV associated with elevated C-reactive protein CRP
DESIGN NARRATIVE
The study has both a nested case-control design and a nested cohort design within the Strong Heart Study SHS an ongoing cohort study of 4549 American Indians The study utilizes previously collected specimens baseline data and the ultrasound measurement of carotid wall thickness IMT in SHS participants Within the initial SHS cohort 400 definite cases of incident myocardial infarction coronary heart disease and stroke are compared with 400 control individuals with no such diagnoses and matched for age gender and residence Their prior serum specimens are analyzed for Chlamydia pneumoniae-specific IgG IgM antibody for cytomegalovirus-specific IgG antibody and for C-reactive protein CRP In addition assays are performed for antibodies to Helicobacter pylori hepatitis A virus HAV and herpes simplex virus HSV type 1 and 2 Correlations are made with baseline parameters of lipids coagulation and adjusted for potential confounding variables of tobacco use pneumonia and altered pulmonary function An additional analysis of a subcohort the above 400 controls is performed looking at the outcome of their carotid IMT a parameter of subclinical atherosclerosis in relation to serologic results indicating a prior exposure to CMV Chlamydia pneumoniae andor other pathogens approximately eight years preceding ultrasound testing Both case-control and cohort analysis are stratified by levels of hemostasis and inflammation including CRP fibrinogen Lpa and plasminogen-activator inhibitor-1 A separate nested substudy performed on peripheral blood mononuclear cells PBMCs prospectively collected from 80 cases and 80 controls examines the host T-cell proliferative response to CMV and other pathogens in relation to disease and also searches for a chronic persistent infection with Chlamydia pneumoniae evidence by DNA detection
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Recent studies have associated evidence of Chlamydia pneumoniae infection with coronary and carotid atherosclerosis and evidence of increased infection with cytomegalovirus CMV in patients developing restenosis or with atherosclerosis Several other common pathogens have been less consistently associated with atherosclerosis Altered parameters of inflammation and hemostasis have been identified as prognostic factors of myocardial infarction and have been linked as possible pathogenetic mechanisms Recent studies have indicated that peripheral blood mononuclear cells PBMC from patients with coronary artery disease frequently include Chlamydia pneumoniae DNA and stimulation of PBMCs can reflect an unsuccessful host cellular immune response to CMV associated with elevated C-reactive protein CRP
DESIGN NARRATIVE
The study has both a nested case-control design and a nested cohort design within the Strong Heart Study SHS an ongoing cohort study of 4549 American Indians The study utilizes previously collected specimens baseline data and the ultrasound measurement of carotid wall thickness IMT in SHS participants Within the initial SHS cohort 400 definite cases of incident myocardial infarction coronary heart disease and stroke are compared with 400 control individuals with no such diagnoses and matched for age gender and residence Their prior serum specimens are analyzed for Chlamydia pneumoniae-specific IgG IgM antibody for cytomegalovirus-specific IgG antibody and for C-reactive protein CRP In addition assays are performed for antibodies to Helicobacter pylori hepatitis A virus HAV and herpes simplex virus HSV type 1 and 2 Correlations are made with baseline parameters of lipids coagulation and adjusted for potential confounding variables of tobacco use pneumonia and altered pulmonary function An additional analysis of a subcohort the above 400 controls is performed looking at the outcome of their carotid IMT a parameter of subclinical atherosclerosis in relation to serologic results indicating a prior exposure to CMV Chlamydia pneumoniae andor other pathogens approximately eight years preceding ultrasound testing Both case-control and cohort analysis are stratified by levels of hemostasis and inflammation including CRP fibrinogen Lpa and plasminogen-activator inhibitor-1 A separate nested substudy performed on peripheral blood mononuclear cells PBMCs prospectively collected from 80 cases and 80 controls examines the host T-cell proliferative response to CMV and other pathogens in relation to disease and also searches for a chronic persistent infection with Chlamydia pneumoniae evidence by DNA detection
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL062233 | NIH | None | httpsreporternihgovquickSearchR01HL062233 |