Framingham Heart Study

• ClinicalTrials.gov Identifier: NCT00005121
• Recruitment Status: Completed
• First Posted: May 26, 2000
• Last Update Posted: April 14, 2016
• Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by: National Heart, Lung, and Blood Institute (NHLBI)

Study Description

Brief Summary:

The Framingham Heart Study was initiated to study the factors associated with the development of cardiovascular disease by employing long-term surveillance of an adult population in Framingham, Massachusetts. The Framingham Offspring Study was initiated to assess familial and genetic factors as determinants of coronary heart disease.

Condition or disease
Cardiovascular Diseases; Heart Diseases; Coronary Disease; Cerebrovascular Accident; Hypertension; Heart Failure, Congestive; Peripheral Vascular Diseases; Arterial Occlusive Diseases; Atherosclerosis; Heart Failure

Detailed Description:

BACKGROUND:

The Framingham Heart Study, initiated in 1948, was designed as a longitudinal investigation of constitutional and environmental factors influencing the development of cardiovascular disease in men and women free of these conditions at the outset. The first person was examined in September 1948 and four years later 5,209 persons had received their first examination. The group has now been followed in the Study for twenty-four subsequent biennial examinations. The need for more information arises from the fact that the epidemiology of cardiovascular disease is incompletely known, estimation of risk is imprecise, and the pattern of cardiovascular disease incidence is changing; these changes need to be documented. Changing patterns of cigarette smoking, nutritional habits and exercise patterns as well as changes in other aspects of lifestyle and advances in medical care may all influence future morbidity and mortality rates for cardiovascular disease. New cases of clinically recognizable cardiovascular disease are less predictable in disease free subjects over age 60, and an already large and growing proportion of the total cardiovascular disease events is now first expressed at these ages. Recently available, technologically advanced measurement tools such as echocardiography need to be evaluated as risk assessors in various age groups. Similarly, the predictive efficacy of recently available lipoprotein cholesterol and apoprotein measurements need to be demonstrated for early onset (age less than 60) as well as later onset cardiovascular disease. Thus, as changes in early detection and treatment of cardiovascular disease advance, prospective epidemiology is needed to document the value and impact of these changes in an organized fashion. Finally, the availability of prospective data on two generations adds to the uniqueness of the Framingham Study among ongoing studies of CVD epidemiology. A determination of the extent and mechanisms by which cardiovascular diseases cluster in families is another important goal of the Framingham Study.

In 1982, the National Institute on Aging initiated a study on senile dementia using the Framingham Heart Study cohort. The study was designed to determine morbidity and mortality outcomes among the 160 subjects identified as suffering from dementia at the 15th biennial examination and to determine incidence of senile dementia among those subjects free of dementia at the 15th biennial examination. Outcome of nursing home admissions was also determined in all study participants.

Biennial comprehensive examinations of the Framingham Heart Study cohort have taken place since 1949. Until examination 12, the study was carried out entirely by the NHLBI. After that time, the Boston University Medical Center, in collaboration with, and using facilities and equipment made available by NHLBI, was responsible for the examinations.

DESIGN NARRATIVE:

Biennial examinations are conducted in the surviving original cohort to obtain information on physical activity, blood pressure, diet, body weight, occupational history, psychosocial factors, and personal habits such as smoking. Special tests include electrocardiographic evaluation, exercise stress test, HLA typing, lipoprotein and apoprotein testing, non-invasive assessment of atherosclerosis, fasting blood glucose, lung function testing, B-scan/Doppler of the carotid and or femoral arteries, and clotting or hemostatic measures. Endpoints include coronary heart disease, stroke, hypertension, congestive heart failure, and peripheral arterial disease.

Members of the Offspring Study were examined for the first time between 1971 and 1975, for the second time between 1979 and 1983, for the third time between 1983 and 1987. Examinations consist of a complete physical examination including resting electrocardiogram, medical history, non-invasive cardiovascular examination, lung function assessment, lipoprotein cholesterol and apoprotein measurements, SMA 25, personal history interview, blood cell ion flux measurement, and platelet function and blood clotting factors measurement.

The 27th exam of approximately 400 survivors of the original cohort is complete. The 28th exam has begun and is ahead of schedule. The 7th exam of the Offspring Cohort began in September 1998 and was completed in December 2001 with 3,500 participants examined. The genome scan is complete with approximately 1,800 samples from 336 families. A Genetics Advisory Panel meets regularly to advise NHLBI on the direction of genetic research within the Framingham Study. Analysis of the genetic and nongenetic data is ongoing and extensive covering such areas as the genetics of lipids, lifetime risk of coronary heart disease, trends in events following Q-wave myocardial infarction, factors affecting left ventricular hypertrophy, and the prevalence and determinants of heart valve disorders.

Initiation of the Third Generation Study was announced in November 2001. Beginning in 2002, the Third Generation Study enrolled 3,900 grandchildren of the Framingham Heart Study's original enrollees. Key goals are to identify new risk factors for heart, lung, and blood diseases, identify genes that contribute to good health and to the development of heart, lung, and blood disease, and to develop new imaging tests that can detect very early stages of coronary atherosclerosis in otherwise healthy adults.

Study Design

• Study Type: Observational
• Study Start Date: July 1948
• Actual Primary Completion Date: September 2008
• Actual Study Completion Date: September 2008

Groups and Cohorts

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: up to 100 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

No eligibility criteria

Contacts and Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• OverallOfficial: Philip Wolf; Boston University

More Information

Study Data/Documents: Individual Participant Data Set 

Identifier: FHS-Cohort
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval, and completion of a data use agreement.

Study Protocol 

Identifier: FHS-Cohort

Study Forms 

Identifier: FHS-Cohort

Data Coding Manuals 

Identifier: FHS-Cohort

Individual Participant Data Set 

Identifier: FHS-OS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval, and completion of a data use agreement.

Study Protocol 

Identifier: FHS-OS

Study Forms 

Identifier: FHS-OS

Data Coding Manuals 

Identifier: FHS-OS

Individual Participant Data Set 

Identifier: FHS-Gen III
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval, and completion of a data use agreement.

Study Protocol 

Identifier: FHS-Gen III

Study Forms 

Identifier: FHS-Gen III

Data Coding Manuals 

Identifier: FHS-Gen III

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang K, Liu H. Association between widespread pain and dementia, Alzheimer's disease and stroke: a cohort study from the Framingham Heart Study. Reg Anesth Pain Med. 2021 Oct;46(10):879-885. doi: 10.1136/rapm-2021-102733. Epub 2021 Aug 16.

Haslam DE, Peloso GM, Guirette M, Imamura F, Bartz TM, Pitsillides AN, Wang CA, Li-Gao R, Westra JM, Pitkanen N, Young KL, Graff M, Wood AC, Braun KVE, Luan J, Kahonen M, Kiefte-de Jong JC, Ghanbari M, Tintle N, Lemaitre RN, Mook-Kanamori DO, North K, Helminen M, Mossavar-Rahmani Y, Snetselaar L, Martin LW, Viikari JS, Oddy WH, Pennell CE, Rosendall FR, Ikram MA, Uitterlinden AG, Psaty BM, Mozaffarian D, Rotter JI, Taylor KD, Lehtimaki T, Raitakari OT, Livingston KA, Voortman T, Forouhi NG, Wareham NJ, de Mutsert R, Rich SS, Manson JE, Mora S, Ridker PM, Merino J, Meigs JB, Dashti HS, Chasman DI, Lichtenstein AH, Smith CE, Dupuis J, Herman MA, McKeown NM. Sugar-Sweetened Beverage Consumption May Modify Associations Between Genetic Variants in the CHREBP (Carbohydrate Responsive Element Binding Protein) Locus and HDL-C (High-Density Lipoprotein Cholesterol) and Triglyceride Concentrations. Circ Genom Precis Med. 2021 Aug;14(4):e003288. doi: 10.1161/CIRCGEN.120.003288. Epub 2021 Jul 16.

Block RC, Shearer GC, Holub A, Tu XM, Mousa S, Brenna JT, Harris WS, Tintle N. Aspirin and omega-3 fatty acid status interact in the prevention of cardiovascular diseases in Framingham Heart Study. Prostaglandins Leukot Essent Fatty Acids. 2021 Jun;169:102283. doi: 10.1016/j.plefa.2021.102283. Epub 2021 Apr 24.

Taron J, Lyass A, Mahoney TF, Ehrbar RQ, Vasan RS, D'Agostino RB Sr, Hoffmann U, Massaro JM, Lu MT. Coronary Artery Calcium Score-Directed Primary Prevention With Statins on the Basis of the 2018 American College of Cardiology/American Heart Association/Multisociety Cholesterol Guidelines. J Am Heart Assoc. 2021 Jan 5;10(1):e018342. doi: 10.1161/JAHA.120.018342. Epub 2020 Dec 22. No abstract available.

Lai CQ, Parnell LD, Smith CE, Guo T, Sayols-Baixeras S, Aslibekyan S, Tiwari HK, Irvin MR, Bender C, Fei D, Hidalgo B, Hopkins PN, Absher DM, Province MA, Elosua R, Arnett DK, Ordovas JM. Carbohydrate and fat intake associated with risk of metabolic diseases through epigenetics of CPT1A. Am J Clin Nutr. 2020 Nov 11;112(5):1200-1211. doi: 10.1093/ajcn/nqaa233.

McKeown NM, Dashti HS, Ma J, Haslam DE, Kiefte-de Jong JC, Smith CE, Tanaka T, Graff M, Lemaitre RN, Rybin D, Sonestedt E, Frazier-Wood AC, Mook-Kanamori DO, Li Y, Wang CA, Leermakers ETM, Mikkila V, Young KL, Mukamal KJ, Cupples LA, Schulz CA, Chen TA, Li-Gao R, Huang T, Oddy WH, Raitakari O, Rice K, Meigs JB, Ericson U, Steffen LM, Rosendaal FR, Hofman A, Kahonen M, Psaty BM, Brunkwall L, Uitterlinden AG, Viikari J, Siscovick DS, Seppala I, North KE, Mozaffarian D, Dupuis J, Orho-Melander M, Rich SS, de Mutsert R, Qi L, Pennell CE, Franco OH, Lehtimaki T, Herman MA. Sugar-sweetened beverage intake associations with fasting glucose and insulin concentrations are not modified by selected genetic variants in a ChREBP-FGF21 pathway: a meta-analysis. Diabetologia. 2018 Feb;61(2):317-330. doi: 10.1007/s00125-017-4475-0. Epub 2017 Nov 2.

Fretts AM, Follis JL, Nettleton JA, Lemaitre RN, Ngwa JS, Wojczynski MK, Kalafati IP, Varga TV, Frazier-Wood AC, Houston DK, Lahti J, Ericson U, van den Hooven EH, Mikkila V, Kiefte-de Jong JC, Mozaffarian D, Rice K, Renstrom F, North KE, McKeown NM, Feitosa MF, Kanoni S, Smith CE, Garcia ME, Tiainen AM, Sonestedt E, Manichaikul A, van Rooij FJ, Dimitriou M, Raitakari O, Pankow JS, Djousse L, Province MA, Hu FB, Lai CQ, Keller MF, Perala MM, Rotter JI, Hofman A, Graff M, Kahonen M, Mukamal K, Johansson I, Ordovas JM, Liu Y, Mannisto S, Uitterlinden AG, Deloukas P, Seppala I, Psaty BM, Cupples LA, Borecki IB, Franks PW, Arnett DK, Nalls MA, Eriksson JG, Orho-Melander M, Franco OH, Lehtimaki T, Dedoussis GV, Meigs JB, Siscovick DS. Consumption of meat is associated with higher fasting glucose and insulin concentrations regardless of glucose and insulin genetic risk scores: a meta-analysis of 50,345 Caucasians. Am J Clin Nutr. 2015 Nov;102(5):1266-78. doi: 10.3945/ajcn.114.101238. Epub 2015 Sep 9.

Cassidy A, Rogers G, Peterson JJ, Dwyer JT, Lin H, Jacques PF. Higher dietary anthocyanin and flavonol intakes are associated with anti-inflammatory effects in a population of US adults. Am J Clin Nutr. 2015 Jul;102(1):172-81. doi: 10.3945/ajcn.115.108555. Epub 2015 May 27.

Dashti HS, Follis JL, Smith CE, Tanaka T, Cade BE, Gottlieb DJ, Hruby A, Jacques PF, Lamon-Fava S, Richardson K, Saxena R, Scheer FA, Kovanen L, Bartz TM, Perala MM, Jonsson A, Frazier-Wood AC, Kalafati IP, Mikkila V, Partonen T, Lemaitre RN, Lahti J, Hernandez DG, Toft U, Johnson WC, Kanoni S, Raitakari OT, Perola M, Psaty BM, Ferrucci L, Grarup N, Highland HM, Rallidis L, Kahonen M, Havulinna AS, Siscovick DS, Raikkonen K, Jorgensen T, Rotter JI, Deloukas P, Viikari JS, Mozaffarian D, Linneberg A, Seppala I, Hansen T, Salomaa V, Gharib SA, Eriksson JG, Bandinelli S, Pedersen O, Rich SS, Dedoussis G, Lehtimaki T, Ordovas JM. Habitual sleep duration is associated with BMI and macronutrient intake and may be modified by CLOCK genetic variants. Am J Clin Nutr. 2015 Jan;101(1):135-43. doi: 10.3945/ajcn.114.095026. Epub 2014 Nov 26.

Dashti HS, Shea MK, Smith CE, Tanaka T, Hruby A, Richardson K, Wang TJ, Nalls MA, Guo X, Liu Y, Yao J, Li D, Johnson WC, Benjamin EJ, Kritchevsky SB, Siscovick DS, Ordovas JM, Booth SL. Meta-analysis of genome-wide association studies for circulating phylloquinone concentrations. Am J Clin Nutr. 2014 Dec;100(6):1462-9. doi: 10.3945/ajcn.114.093146. Epub 2014 Oct 8.

Hunninghake GM, Hatabu H, Okajima Y, Gao W, Dupuis J, Latourelle JC, Nishino M, Araki T, Zazueta OE, Kurugol S, Ross JC, San Jose Estepar R, Murphy E, Steele MP, Loyd JE, Schwarz MI, Fingerlin TE, Rosas IO, Washko GR, O'Connor GT, Schwartz DA. MUC5B promoter polymorphism and interstitial lung abnormalities. N Engl J Med. 2013 Jun 6;368(23):2192-200. doi: 10.1056/NEJMoa1216076. Epub 2013 May 21.

Tanaka T, Ngwa JS, van Rooij FJ, Zillikens MC, Wojczynski MK, Frazier-Wood AC, Houston DK, Kanoni S, Lemaitre RN, Luan J, Mikkila V, Renstrom F, Sonestedt E, Zhao JH, Chu AY, Qi L, Chasman DI, de Oliveira Otto MC, Dhurandhar EJ, Feitosa MF, Johansson I, Khaw KT, Lohman KK, Manichaikul A, McKeown NM, Mozaffarian D, Singleton A, Stirrups K, Viikari J, Ye Z, Bandinelli S, Barroso I, Deloukas P, Forouhi NG, Hofman A, Liu Y, Lyytikainen LP, North KE, Dimitriou M, Hallmans G, Kahonen M, Langenberg C, Ordovas JM, Uitterlinden AG, Hu FB, Kalafati IP, Raitakari O, Franco OH, Johnson A, Emilsson V, Schrack JA, Semba RD, Siscovick DS, Arnett DK, Borecki IB, Franks PW, Kritchevsky SB, Lehtimaki T, Loos RJ, Orho-Melander M, Rotter JI, Wareham NJ, Witteman JC, Ferrucci L, Dedoussis G, Cupples LA, Nettleton JA. Genome-wide meta-analysis of observational studies shows common genetic variants associated with macronutrient intake. Am J Clin Nutr. 2013 Jun;97(6):1395-402. doi: 10.3945/ajcn.112.052183. Epub 2013 May 1.

• ClinicalTrials.gov Identifier: NCT00005121
• Other Study ID Numbers: 900
• First Posted: May 26, 2000
• Last Update Posted: April 14, 2016
• Last Verified: April 2009

Additional relevant MeSH terms:

Stroke; Heart Failure; Cardiovascular Diseases; Atherosclerosis; Vascular Diseases; Coronary Disease; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arterial Occlusive Diseases; Heart Diseases; Arteriosclerosis; Myocardial Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases