Heart ArrestNCT00005259
Polyunsaturated Fats and Risk of Primary Cardiac Arrest
An observational study of Heart Arrest and Cardiovascular Diseases, run by University of Washington.
Trial summary
To determine whether the dietary intake of trans-fatty acids derived from partially hydrogenated unsaturated fatty acids measured through a biomarker are directly associated with the risk of primary cardiac arrest. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Heart Arrest, Cardiovascular Diseases, Heart Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1990to Mar 2007
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine whether the dietary intake of trans-fatty acids derived from partially hydrogenated unsaturated fatty acids measured through a biomarker are directly associated with the risk of primary cardiac arrest.
Read the detailed description
BACKGROUND:
The potential role of omega-3 PUFA intake in the prevention of coronary heart disease is supported by studies among Greenland Eskimos, the Japanese, the Dutch, and data from the Western Electric Study. The low incidence of coronary heart disease among Eskimos and Japanese populations has been attributed to high dietary intake of fish oils. In addition, a large cohort study from the Netherlands found an inverse relationship between regular fish consumption and coronary heart disease mortality. Mortality from coronary heart disease was increased 2.5 fold among persons who did not consume fish compared to those who consumed at least 30 grams/day or the equivalent of 1-2 fish meals per week. There was no evidence that increasing fish intake above 30 grams per day provided additional benefit; moderate intake had the greatest effect on coronary heart disease mortality. Dietary omega-3 PUFA intake, though modest, was also inversely related to coronary heart disease mortality. Analysis of dietary data from the Western Electric Study cohort also suggested an inverse relation between fish consumption and coronary heart disease mortality. In contrast, cohort studies from Hawaii and Norway observed no relation between fish consumption and coronary heart disease. However, fish consumption was higher in these populations and there were few individuals who did not consume fish. Prior to the present study, there had been no studies of the relation between dietary fish intake and the risk of primary cardiac arrest.
DESIGN NARRATIVE:
The study has a case-control design. Beginning in July 1990, through Emergency Medical Service incident reports, all cases of primary cardiac arrest, ages 25-74, without prior clinical heart diseases, were identified in Seattle and suburban King County, Washington during the period April 1990 to March 1994. Controls were identified from the same community using random digit dialing. Blood specimens from cases and controls were analyzed to determine red-cell membrane fatty acid composition. Spouses of cases and controls were interviewed to assess dietary intake of long-chain omega-3 PUFAs (a function of the amount of seafood consumed), usual fat consumption, changes in dietary intake, and presence or absence of other risk factors for primary cardiac arrest. Analyses were conducted to assess the relation between dietary intake and red-cell membrane omega-3-fatty acid levels and to assess whether there was a threshold or dose response effect for each fatty acid.
The study was renewed in 1996 through June, 2000. During the initial funding period studies were conducted on the relationship to primary cardiac arrest of dietary intake of long chain n-3 polyunsaturated fatty acids from seafood. The investigators are now extending the population-based, case-control study to determine whether the dietary intake of trans-fatty acids derived from partially hydrogenated unsaturated fatty acids measured through a biomarker are directly associated with the risk of primary cardiac arrest. Cases of PCA who were attended by paramedics in King County, Washington are identified. Demographically similar controls are identified from the same community using random digit dialing. Blood specimens from both previously identified and newly identified cases (collected by paramedics in the field) and controls are analyzed for red cell membrane total trans-fatty acid levels. This serves as a biomarker of dietary trans-fatty acid intake.
Spouses of subjects are interviewed to obtain information on usual saturated fat intake, recent changes in diet and other risk factors. Additionally, among spouses of newly identified subjects, the types of fat used in cooking and as spreads are assessed. Analyses focus on the relationship between red cell membrane total trans-fatty acid levels and the risk of PCA after adjusting for saturated fat intake and other risk factors.
The investigators also plan to extend a detailed diet substudy in a subset of control subjects to confirm the relationship between the dietary intake of trans-fatty acids and red cell membrane levels and evaluate whether the relationship is independent of other nutrients.
The study has been renewed through March 2006.
- Conditions
- Heart Arrest, Cardiovascular Diseases, Heart Diseases
- Medical subject headings
- Heart Arrest, Cardiovascular Diseases, Heart Diseases
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 startJul 1990
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Siscovick, University of Washington
- Investigators
- David Siscovick, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005259
- Sponsor's protocol ID
- 10030-C
- Other IDs
- R01HL041993
- Status last verified
- Oct 2016
- First submitted
- 25 May 2000
- Last updated
- 31 Oct 2016
- Results posted
- No
Publications
Friedlander Y, Siscovick DS, Weinmann S, Austin MA, Psaty BM, Lemaitre RN, Arbogast P, Raghunathan TE, Cobb LA. Family history as a risk factor for primary cardiac arrest. Circulation. 1998 Jan 20;97(2):155-60. doi: 10.1161/01.cir.97.2.155.
PubMed 9445167Weinmann S, Siscovick DS, Raghunathan TE, Arbogast P, Smith H, Bovbjerg VE, Cobb LA, Psaty BM. Caffeine intake in relation to the risk of primary cardiac arrest. Epidemiology. 1997 Sep;8(5):505-8. doi: 10.1097/00001648-199709000-00006.
PubMed 9270951Siscovick DS, Raghunathan TE, King I, Weinmann S, Wicklund KG, Albright J, Bovbjerg V, Arbogast P, Smith H, Kushi LH, et al. Dietary intake and cell membrane levels of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest. JAMA. 1995 Nov 1;274(17):1363-7. doi: 10.1001/jama.1995.03530170043030.
PubMed 7563561Siscovick DS, Raghunathan T, King I, Weinmann S, Bovbjerg VE, Kushi L, Cobb LA, Copass MK, Psaty BM, Lemaitre R, Retzlaff B, Knopp RH. Dietary intake of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest. Am J Clin Nutr. 2000 Jan;71(1 Suppl):208S-12S. doi: 10.1093/ajcn/71.1.208S.
PubMed 10617973Lemaitre RN, Siscovick DS, Raghunathan TE, Weinmann S, Arbogast P, Lin DY. Leisure-time physical activity and the risk of primary cardiac arrest. Arch Intern Med. 1999 Apr 12;159(7):686-90. doi: 10.1001/archinte.159.7.686.
PubMed 10218747Weinmann S, Siscovick DS, Raghunathan TE, Handsfield H, Copass M, Cobb LA. Human immunodeficiency virus seroprevalence among adults treated for out-of-hospital cardiac arrest in Seattle, Washington, 1989-1993. Ann Emerg Med. 1998 Aug;32(2):148-50. doi: 10.1016/s0196-0644(98)70129-5.
PubMed 9701296Lemaitre RN, King IB, Raghunathan TE, Pearce RM, Weinmann S, Knopp RH, Copass MK, Cobb LA, Siscovick DS. Cell membrane trans-fatty acids and the risk of primary cardiac arrest. Circulation. 2002 Feb 12;105(6):697-701. doi: 10.1161/hc0602.103583.
PubMed 11839624Friedlander Y, Siscovick DS, Arbogast P, Psaty BM, Weinmann S, Lemaitre RN, Raghunathan TE, Cobb LA. Sudden death and myocardial infarction in first degree relatives as predictors of primary cardiac arrest. Atherosclerosis. 2002 May;162(1):211-6. doi: 10.1016/s0021-9150(01)00701-8.
PubMed 11947916Reiner AP, Rosendaal FR, Reitsma PH, Lemaitre RN, Pearce RM, Friedlander Y, Raghunathan TE, Psaty BM, Siscovick DS. Factor V Leiden, prothrombin G20210A, and risk of sudden coronary death in apparently healthy persons. Am J Cardiol. 2002 Jul 1;90(1):66-8. doi: 10.1016/s0002-9149(02)02391-3. No abstract available.
PubMed 12088785Longstreth WT Jr, Schellenberg GD, Fahrenbruch CE, Cobb LA, Copass MK, Siscovick DS. Apolipoprotein E genotypes and outcome from out of hospital cardiac arrest. J Neurol Neurosurg Psychiatry. 2003 Oct;74(10):1441-3. doi: 10.1136/jnnp.74.10.1441.
PubMed 14570844
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyunsaturated Fats and Risk of Primary Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00005259
- Acronym / sponsor ID
- 10030-C
- Conditions
- Heart Arrest, Cardiovascular Diseases, Heart Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1990
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (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 determine whether the dietary intake of trans-fatty acids derived from partially hydrogenated unsaturated fatty acids measured through a biomarker are directly associated with the risk of primary cardiac arrest.
Detailed description
BACKGROUND:
The potential role of omega-3 PUFA intake in the prevention of coronary heart disease is supported by studies among Greenland Eskimos, the Japanese, the Dutch, and data from the Western Electric Study. The low incidence of coronary heart disease among Eskimos and Japanese populations has been attributed to high dietary intake of fish oils. In addition, a large cohort study from the Netherlands found an inverse relationship between regular fish consumption and coronary heart disease mortality. Mortality from coronary heart disease was increased 2.5 fold among persons who did not consume fish compared to those who consumed at least 30 grams/day or the equivalent of 1-2 fish meals per week. There was no evidence that increasing fish intake above 30 grams per day provided additional benefit; moderate intake had the greatest effect on coronary heart disease mortality. Dietary omega-3 PUFA intake, though modest, was also inversely related to coronary heart disease mortality. Analysis of dietary data from the Western Electric Study cohort also suggested an inverse relation between fish consumption and coronary heart disease mortality. In contrast, cohort studies from Hawaii and Norway observed no relation between fish consumption and coronary heart disease. However, fish consumption was higher in these populations and there were few individuals who did not consume fish. Prior to the present study, there had been no studies of the relation between dietary fish intake and the risk of primary cardiac arrest.
DESIGN NARRATIVE:
The study has a case-control design. Beginning in July 1990, through Emergency Medical Service incident reports, all cases of primary cardiac arrest, ages 25-74, without prior clinical heart diseases, were identified in Seattle and suburban King County, Washington during the period April 1990 to March 1994. Controls were identified from the same community using random digit dialing. Blood specimens from cases and controls were analyzed to determine red-cell membrane fatty acid composition. Spouses of cases and controls were interviewed to assess dietary intake of long-chain omega-3 PUFAs (a function of the amount of seafood consumed), usual fat consumption, changes in dietary intake, and presence or absence of other risk factors for primary cardiac arrest. Analyses were conducted to assess the relation between dietary intake and red-cell membrane omega-3-fatty acid levels and to assess whether there was a threshold or dose response effect for each fatty acid.
The study was renewed in 1996 through June, 2000. During the initial funding period studies were conducted on the relationship to primary cardiac arrest of dietary intake of long chain n-3 polyunsaturated fatty acids from seafood. The investigators are now extending the population-based, case-control study to determine whether the dietary intake of trans-fatty acids derived from partially hydrogenated unsaturated fatty acids measured through a biomarker are directly associated with the risk of primary cardiac arrest. Cases of PCA who were attended by paramedics in King County, Washington are identified. Demographically similar controls are identified from the same community using random digit dialing. Blood specimens from both previously identified and newly identified cases (collected by paramedics in the field) and controls are analyzed for red cell membrane total trans-fatty acid levels. This serves as a biomarker of dietary trans-fatty acid intake.
Spouses of subjects are interviewed to obtain information on usual saturated fat intake, recent changes in diet and other risk factors. Additionally, among spouses of newly identified subjects, the types of fat used in cooking and as spreads are assessed. Analyses focus on the relationship between red cell membrane total trans-fatty acid levels and the risk of PCA after adjusting for saturated fat intake and other risk factors.
The investigators also plan to extend a detailed diet substudy in a subset of control subjects to confirm the relationship between the dietary intake of trans-fatty acids and red cell membrane levels and evaluate whether the relationship is independent of other nutrients.
The study has been renewed through March 2006.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- 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 31 Oct 2016.
- Background: PubMed 9445167Friedlander Y, Siscovick DS, Weinmann S, Austin MA, Psaty BM, Lemaitre RN, Arbogast P, Raghunathan TE, Cobb LA. Family history as a risk factor for primary cardiac arrest. Circulation. 1998 Jan 20;97(2):155-60. doi: 10.1161/01.cir.97.2.155.
- Background: PubMed 9270951Weinmann S, Siscovick DS, Raghunathan TE, Arbogast P, Smith H, Bovbjerg VE, Cobb LA, Psaty BM. Caffeine intake in relation to the risk of primary cardiac arrest. Epidemiology. 1997 Sep;8(5):505-8. doi: 10.1097/00001648-199709000-00006.
- Background: PubMed 7563561Siscovick DS, Raghunathan TE, King I, Weinmann S, Wicklund KG, Albright J, Bovbjerg V, Arbogast P, Smith H, Kushi LH, et al. Dietary intake and cell membrane levels of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest. JAMA. 1995 Nov 1;274(17):1363-7. doi: 10.1001/jama.1995.03530170043030.
- Background: PubMed 10617973Siscovick DS, Raghunathan T, King I, Weinmann S, Bovbjerg VE, Kushi L, Cobb LA, Copass MK, Psaty BM, Lemaitre R, Retzlaff B, Knopp RH. Dietary intake of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest. Am J Clin Nutr. 2000 Jan;71(1 Suppl):208S-12S. doi: 10.1093/ajcn/71.1.208S.
- Background: PubMed 10218747Lemaitre RN, Siscovick DS, Raghunathan TE, Weinmann S, Arbogast P, Lin DY. Leisure-time physical activity and the risk of primary cardiac arrest. Arch Intern Med. 1999 Apr 12;159(7):686-90. doi: 10.1001/archinte.159.7.686.
- Background: PubMed 9701296Weinmann S, Siscovick DS, Raghunathan TE, Handsfield H, Copass M, Cobb LA. Human immunodeficiency virus seroprevalence among adults treated for out-of-hospital cardiac arrest in Seattle, Washington, 1989-1993. Ann Emerg Med. 1998 Aug;32(2):148-50. doi: 10.1016/s0196-0644(98)70129-5.
- Background: PubMed 11839624Lemaitre RN, King IB, Raghunathan TE, Pearce RM, Weinmann S, Knopp RH, Copass MK, Cobb LA, Siscovick DS. Cell membrane trans-fatty acids and the risk of primary cardiac arrest. Circulation. 2002 Feb 12;105(6):697-701. doi: 10.1161/hc0602.103583.
- Background: PubMed 11947916Friedlander Y, Siscovick DS, Arbogast P, Psaty BM, Weinmann S, Lemaitre RN, Raghunathan TE, Cobb LA. Sudden death and myocardial infarction in first degree relatives as predictors of primary cardiac arrest. Atherosclerosis. 2002 May;162(1):211-6. doi: 10.1016/s0021-9150(01)00701-8.
- Background: PubMed 12088785Reiner AP, Rosendaal FR, Reitsma PH, Lemaitre RN, Pearce RM, Friedlander Y, Raghunathan TE, Psaty BM, Siscovick DS. Factor V Leiden, prothrombin G20210A, and risk of sudden coronary death in apparently healthy persons. Am J Cardiol. 2002 Jul 1;90(1):66-8. doi: 10.1016/s0002-9149(02)02391-3. No abstract available.
- Background: PubMed 14570844Longstreth WT Jr, Schellenberg GD, Fahrenbruch CE, Cobb LA, Copass MK, Siscovick DS. Apolipoprotein E genotypes and outcome from out of hospital cardiac arrest. J Neurol Neurosurg Psychiatry. 2003 Oct;74(10):1441-3. doi: 10.1136/jnnp.74.10.1441.
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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.
David Siscovick
University of Washington
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Arrest and Cardiovascular Diseases, run by University of Washington.
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 31 Oct 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 NCT00005259, which also lists 10 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 31 Oct 2016.