Cardiovascular DiseasesNCT00005371
Epidemiology of Acute Phase Protein and CHD
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality. 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, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1993to Mar 1995
- 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 use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality.
Read the detailed description
BACKGROUND:
The use of stored serum from the MRFIT cohort contributed additional information on how various lipid fractions and other serum constituents interact to produce atherosclerotic disease. The cost of performing such studies on a new cohort would be many times greater.
DESIGN NARRATIVE:
The case-control study evaluated: 1) the relationship between acute phase reactants, albumin, alpha 1 glycoprotein c-reactive protein and sialic acid; 2) oxidized low density lipoprotein cholesterol (LDLC) measured by thiobarbituric acid reactive substances (TBARS), and risk of myocardial infarction or coronary heart disease death; 3) Lp(a); 4) antioxidized vitamin E and carotene. The study was done in one year because of the need to analyze the specimens shortly after they were thawed. The statistical analysis was done in collaboration with University of Minnesota Coordinating Center.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Heart Diseases, Atherosclerosis
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 1993
- Study completionMar 1995
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Lewis Kuller, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005371
- Sponsor's protocol ID
- 4262
- Other IDs
- R01HL049872
- Status last verified
- Mar 2005
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Acute Phase Protein and CHD
- ClinicalTrials.gov ID
- NCT00005371
- Acronym / sponsor ID
- 4262
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1993
- Study completion
- Mar 1995 (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 use the Multiple Risk Factor Intervention Trial (MRFIT) stored serum bank to do nested case-control studies of various serum risk factors in coronary heart disease incidence and mortality.
Detailed description
BACKGROUND:
The use of stored serum from the MRFIT cohort contributed additional information on how various lipid fractions and other serum constituents interact to produce atherosclerotic disease. The cost of performing such studies on a new cohort would be many times greater.
DESIGN NARRATIVE:
The case-control study evaluated: 1) the relationship between acute phase reactants, albumin, alpha 1 glycoprotein c-reactive protein and sialic acid; 2) oxidized low density lipoprotein cholesterol (LDLC) measured by thiobarbituric acid reactive substances (TBARS), and risk of myocardial infarction or coronary heart disease death; 3) Lp(a); 4) antioxidized vitamin E and carotene. The study was done in one year because of the need to analyze the specimens shortly after they were thawed. The statistical analysis was done in collaboration with University of Minnesota Coordinating Center.
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 13 May 2016.
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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.
Lewis Kuller
University of Pittsburgh
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 13 May 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?
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 13 May 2016.