Cardiovascular DiseasesNCT00005242
Childhood Passive Smoking: Cohort Study of Cardiac Risk
An observational study of Cardiovascular Diseases and Heart Diseases, run by Virginia Commonwealth University.
Trial summary
To determine the effects of long-term exposure to passive smoking on the cardiovascular and oxygen transport systems in pre-adolescent twins. 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, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 1989to Jun 1994
- 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 determine the effects of long-term exposure to passive smoking on the cardiovascular and oxygen transport systems in pre-adolescent twins.
Read the detailed description
BACKGROUND:
The adverse health effects of actively inhaled cigarette smoke include impaired pulmonary function, increased coronary and cerebrovascular disease, chronic pulmonary disease, and cancer. Infants and young children of smoking parents are at increased risk for lower respiratory tract infections and small airways disease than are children of non-smoking parents. What is less clear is how the oxygen transport system of the growing child is affected by the long-term exposure to and passive inhalation of cigarette smoke and if this exposure represents a risk for the subsequent development of atherosclerotic heart disease.
DESIGN NARRATIVE:
A sample of 300 pre-adolescent twin pairs was recruited from an established population-based twin study. The three cohorts of twins and their parents were initially evaluated in a cross-sectional study and then followed longitudinally for up to three years. In the initial testing cycle the following data were collected: genotype; general health; anthropometric measures; resting and exercise noninvasive evaluation of hemodynamic parameters including blood pressure, heart rate, cardiac output, left ventricular mass, and oxygen consumption; hematocrit and blood levels of 2,3-DPG, cotinine, thiocyanate, and erythropoietin; spirometric and pulmonary flow data; lipid levels. There were three follow-up exams. The availability of repeated measures of oxygen delivery and its determinants in twins and their parents permitted both a unique analysis of genetic and environmental factors during the process of developmental change and measurements of the risks of accelerated atherosclerotic/ischemic heart disease and of the development of reactive airway disease.
The following hypotheses were tested: genetic factors accounted for a significant proportion of the variation in the hematologic and cardiovascular determinants of systemic oxygen delivery; adaptive responses of the oxygen delivery system differed in the same individual before and after puberty; passive smoking in children was an incremental risk factor for the development of accelerated atherosclerotic/ischemic cardiovascular disease; passive smoking in children was a contributing factor in the development of reactive airway disease.
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Lung Diseases, Coronary Artery Disease
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 1989
- Study completionJun 1994
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 Virginia Commonwealth UniversityThe 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
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005242
- Sponsor's protocol ID
- 1123
- Other IDs
- R29HL038878
- Status last verified
- Feb 2016
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Moskowitz WB, Mosteller M, Schieken RM, Bossano R, Hewitt JK, Bodurtha JN, Segrest JP. Lipoprotein and oxygen transport alterations in passive smoking preadolescent children. The MCV Twin Study. Circulation. 1990 Feb;81(2):586-92. doi: 10.1161/01.cir.81.2.586.
PubMed 2297864Schieken RM, Mosteller M, Goble MM, Moskowitz WB, Hewitt JK, Eaves LJ, Nance WE. Multivariate genetic analysis of blood pressure and body size. The Medical College of Virginia Twin Study. Circulation. 1992 Dec;86(6):1780-8. doi: 10.1161/01.cir.86.6.1780.
PubMed 1451250Goble MM, Mosteller M, Moskowitz WB, Schieken RM. Sex differences in the determinants of left ventricular mass in childhood. The Medical College of Virginia Twin Study. Circulation. 1992 May;85(5):1661-5. doi: 10.1161/01.cir.85.5.1661.
PubMed 1572024Newkumet KM, Goble MM, Young RB, Kaplowitz PB, Schieken RM. Altered blood pressure reactivity in adolescent diabetics. Pediatrics. 1994 Apr;93(4):616-21.
PubMed 8134217Moskowitz WB, Mosteller M, Hewitt JK, Eaves LJ, Nance WE, Schieken RM. Univariate genetic analysis of oxygen transport regulation in children: the Medical College of Virginia Twin Study. Pediatr Res. 1993 Jun;33(6):645-8. doi: 10.1203/00006450-199306000-00022.
PubMed 8378126
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childhood Passive Smoking: Cohort Study of Cardiac Risk
- ClinicalTrials.gov ID
- NCT00005242
- Acronym / sponsor ID
- 1123
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 1989
- Study completion
- Jun 1994
- 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 determine the effects of long-term exposure to passive smoking on the cardiovascular and oxygen transport systems in pre-adolescent twins.
Detailed description
BACKGROUND:
The adverse health effects of actively inhaled cigarette smoke include impaired pulmonary function, increased coronary and cerebrovascular disease, chronic pulmonary disease, and cancer. Infants and young children of smoking parents are at increased risk for lower respiratory tract infections and small airways disease than are children of non-smoking parents. What is less clear is how the oxygen transport system of the growing child is affected by the long-term exposure to and passive inhalation of cigarette smoke and if this exposure represents a risk for the subsequent development of atherosclerotic heart disease.
DESIGN NARRATIVE:
A sample of 300 pre-adolescent twin pairs was recruited from an established population-based twin study. The three cohorts of twins and their parents were initially evaluated in a cross-sectional study and then followed longitudinally for up to three years. In the initial testing cycle the following data were collected: genotype; general health; anthropometric measures; resting and exercise noninvasive evaluation of hemodynamic parameters including blood pressure, heart rate, cardiac output, left ventricular mass, and oxygen consumption; hematocrit and blood levels of 2,3-DPG, cotinine, thiocyanate, and erythropoietin; spirometric and pulmonary flow data; lipid levels. There were three follow-up exams. The availability of repeated measures of oxygen delivery and its determinants in twins and their parents permitted both a unique analysis of genetic and environmental factors during the process of developmental change and measurements of the risks of accelerated atherosclerotic/ischemic heart disease and of the development of reactive airway disease.
The following hypotheses were tested: genetic factors accounted for a significant proportion of the variation in the hematologic and cardiovascular determinants of systemic oxygen delivery; adaptive responses of the oxygen delivery system differed in the same individual before and after puberty; passive smoking in children was an incremental risk factor for the development of accelerated atherosclerotic/ischemic cardiovascular disease; passive smoking in children was a contributing factor in the development of reactive airway disease.
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 29 Feb 2016.
- Background: PubMed 2297864Moskowitz WB, Mosteller M, Schieken RM, Bossano R, Hewitt JK, Bodurtha JN, Segrest JP. Lipoprotein and oxygen transport alterations in passive smoking preadolescent children. The MCV Twin Study. Circulation. 1990 Feb;81(2):586-92. doi: 10.1161/01.cir.81.2.586.
- Background: PubMed 1451250Schieken RM, Mosteller M, Goble MM, Moskowitz WB, Hewitt JK, Eaves LJ, Nance WE. Multivariate genetic analysis of blood pressure and body size. The Medical College of Virginia Twin Study. Circulation. 1992 Dec;86(6):1780-8. doi: 10.1161/01.cir.86.6.1780.
- Background: PubMed 1572024Goble MM, Mosteller M, Moskowitz WB, Schieken RM. Sex differences in the determinants of left ventricular mass in childhood. The Medical College of Virginia Twin Study. Circulation. 1992 May;85(5):1661-5. doi: 10.1161/01.cir.85.5.1661.
- Background: PubMed 8134217Newkumet KM, Goble MM, Young RB, Kaplowitz PB, Schieken RM. Altered blood pressure reactivity in adolescent diabetics. Pediatrics. 1994 Apr;93(4):616-21.
- Background: PubMed 8378126Moskowitz WB, Mosteller M, Hewitt JK, Eaves LJ, Nance WE, Schieken RM. Univariate genetic analysis of oxygen transport regulation in children: the Medical College of Virginia Twin Study. Pediatr Res. 1993 Jun;33(6):645-8. doi: 10.1203/00006450-199306000-00022.
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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 Virginia Commonwealth University.
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 29 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 NCT00005242, 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 29 Feb 2016.