Cardiovascular DiseasesNCT00005547
Infection and Cardiovascular Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Accident
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1999to Jun 2003
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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 4,549 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, and/or 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, Lp(a), 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.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Accident, Heart Diseases, Myocardial Infarction, Infection
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Stroke, Heart Diseases, Myocardial Infarction, Infections, Chlamydia Infections, Cytomegalovirus Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startApr 1999
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Michael Davidson, Medlantic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005547
- Sponsor's protocol ID
- 5091
- Other IDs
- R01HL062233
- Status last verified
- Jan 2005
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Best LG, Davidson M, North KE, MacCluer JW, Zhang Y, Lee ET, Howard BV, DeCroo S, Ferrell RE. Prospective analysis of mannose-binding lectin genotypes and coronary artery disease in American Indians: the Strong Heart Study. Circulation. 2004 Feb 3;109(4):471-5. doi: 10.1161/01.CIR.0000109757.95461.10. Epub 2004 Jan 19.
PubMed 14732744
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infection and Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT00005547
- Acronym / sponsor ID
- 5091
- Conditions
- Cardiovascular Diseases, Coronary Disease, Cerebrovascular Accident, Heart Diseases, Myocardial Infarction, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1999
- Study completion
- Jun 2003 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 4,549 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, and/or 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, Lp(a), 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 design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 14732744Best LG, Davidson M, North KE, MacCluer JW, Zhang Y, Lee ET, Howard BV, DeCroo S, Ferrell RE. Prospective analysis of mannose-binding lectin genotypes and coronary artery disease in American Indians: the Strong Heart Study. Circulation. 2004 Feb 3;109(4):471-5. doi: 10.1161/01.CIR.0000109757.95461.10. Epub 2004 Jan 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Davidson
Medlantic Research Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005547, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.