Cardiovascular DiseasesNCT00005439
Evaluation of Childhood Blood Pressure and Lipid Screening
An observational study of Cardiovascular Diseases and Heart Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1992to Mar 1997
- 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 help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood.
Read the detailed description
BACKGROUND:
To be useful, a screening program depends on an acceptable, valid, and reliable test, and an efficacious and cost-effective intervention in the population of interest. Screening children to detect those at high risk of adult hypertension or hypercholesterolemia was examined from this viewpoint. Long-term studies starting in childhood have so far revealed less than optimal validity of blood pressure and serum cholesterol levels in childhood as predictors of adult levels. However, information was sparse regarding reliability of measurements, accounting for which could improve validity. The efficacy of interventions that could be widely applied in childhood had not yet been demonstrated. In addition, the costs of an extensive screening program and risks such as misclassification, side effects, and labeling needed to be evaluated. The results of this study helped determine whether screening for risk factors in childhood was a useful method for preventing cardiovascular disease in adults.
DESIGN NARRATIVE:
The study examined the following factors that were key elements in the evaluation of screening: 1) within-person variability of BP and lipid measurements (i.e., the reliability of the test) and its impact on tracking of BP and lipids from childhood to adulthood, 2) calculation of predictive values, sensitivity, and specificity of childhood BP and lipid measurements considered as screening tests for adult values, after correcting for within-person variability (i.e., validity), 3) one potentially effective intervention for BP control in children, that is, calcium supplementation, and 4) evaluating the cost-effectiveness of screening to identify children at high risk of developing adult hypertension or hyperlipidemia.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Hypercholesterolemia, Hypertension
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 1992
- Study completionMar 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005439
- Sponsor's protocol ID
- 4367
- Other IDs
- R29HL048236
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Gillman MW, Cook NR, Evans DA, Rosner B, Hennekens CH. Relationship of alcohol intake with blood pressure in young adults. Hypertension. 1995 May;25(5):1106-10. doi: 10.1161/01.hyp.25.5.1106.
PubMed 7737723Gillman MW, Cupples LA, Gagnon D, Millen BE, Ellison RC, Castelli WP. Margarine intake and subsequent coronary heart disease in men. Epidemiology. 1997 Mar;8(2):144-9. doi: 10.1097/00001648-199703000-00004.
PubMed 9229205Cook NR, Gillman MW, Rosner BA, Taylor JO, Hennekens CH. Prediction of young adult blood pressure from childhood blood pressure, height, and weight. J Clin Epidemiol. 1997 May;50(5):571-9. doi: 10.1016/s0895-4356(97)00046-2.
PubMed 9180649Gillman MW, Cook NR. Blood pressure measurement in childhood epidemiological studies. Circulation. 1995 Aug 15;92(4):1049-57. doi: 10.1161/01.cir.92.4.1049.
PubMed 7641339Gillman MW, Cupples LA, Gagnon D, Posner BM, Ellison RC, Castelli WP, Wolf PA. Protective effect of fruits and vegetables on development of stroke in men. JAMA. 1995 Apr 12;273(14):1113-7. doi: 10.1001/jama.1995.03520380049034.
PubMed 7707599
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
- Evaluation of Childhood Blood Pressure and Lipid Screening
- ClinicalTrials.gov ID
- NCT00005439
- Acronym / sponsor ID
- 4367
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 1992
- Study completion
- Mar 1997 (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 help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood.
Detailed description
BACKGROUND:
To be useful, a screening program depends on an acceptable, valid, and reliable test, and an efficacious and cost-effective intervention in the population of interest. Screening children to detect those at high risk of adult hypertension or hypercholesterolemia was examined from this viewpoint. Long-term studies starting in childhood have so far revealed less than optimal validity of blood pressure and serum cholesterol levels in childhood as predictors of adult levels. However, information was sparse regarding reliability of measurements, accounting for which could improve validity. The efficacy of interventions that could be widely applied in childhood had not yet been demonstrated. In addition, the costs of an extensive screening program and risks such as misclassification, side effects, and labeling needed to be evaluated. The results of this study helped determine whether screening for risk factors in childhood was a useful method for preventing cardiovascular disease in adults.
DESIGN NARRATIVE:
The study examined the following factors that were key elements in the evaluation of screening: 1) within-person variability of BP and lipid measurements (i.e., the reliability of the test) and its impact on tracking of BP and lipids from childhood to adulthood, 2) calculation of predictive values, sensitivity, and specificity of childhood BP and lipid measurements considered as screening tests for adult values, after correcting for within-person variability (i.e., validity), 3) one potentially effective intervention for BP control in children, that is, calcium supplementation, and 4) evaluating the cost-effectiveness of screening to identify children at high risk of developing adult hypertension or hyperlipidemia.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) recor
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 7737723Gillman MW, Cook NR, Evans DA, Rosner B, Hennekens CH. Relationship of alcohol intake with blood pressure in young adults. Hypertension. 1995 May;25(5):1106-10. doi: 10.1161/01.hyp.25.5.1106.
- Background: PubMed 9229205Gillman MW, Cupples LA, Gagnon D, Millen BE, Ellison RC, Castelli WP. Margarine intake and subsequent coronary heart disease in men. Epidemiology. 1997 Mar;8(2):144-9. doi: 10.1097/00001648-199703000-00004.
- Background: PubMed 9180649Cook NR, Gillman MW, Rosner BA, Taylor JO, Hennekens CH. Prediction of young adult blood pressure from childhood blood pressure, height, and weight. J Clin Epidemiol. 1997 May;50(5):571-9. doi: 10.1016/s0895-4356(97)00046-2.
- Background: PubMed 7641339Gillman MW, Cook NR. Blood pressure measurement in childhood epidemiological studies. Circulation. 1995 Aug 15;92(4):1049-57. doi: 10.1161/01.cir.92.4.1049.
- Background: PubMed 7707599Gillman MW, Cupples LA, Gagnon D, Posner BM, Ellison RC, Castelli WP, Wolf PA. Protective effect of fruits and vegetables on development of stroke in men. JAMA. 1995 Apr 12;273(14):1113-7. doi: 10.1001/jama.1995.03520380049034.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Heart Diseases, 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 NCT00005439, which also lists 5 linked publications.
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.