Designing a prospective cohort study for cardiovascular intervention scientific research pubrica

Designing a ProspectiveCohort Study forCardiovascular Intervention

Designing a ProspectiveCohort Study forCardiovascular InterventionAn Academic presentation byDr. Nancy Agens, Head, Technical Operations, PubricaGroup:  www.pubrica.comEmail: [email protected]

Briefing

Intervention

Conclusion

OUTLINE OF TOPICS

Today's DiscussionToday's Discussion

Briefing

Intervention

Conclusion

OUTLINE OF TOPICS

Today's DiscussionToday's Discussion

BriefingBriefing

Approximately, 30% of death among the health complications occurs due to thedisorders in heart and blood vessel. This health problem is known to be

cardiovascular diseases (CVD). In most of CVD, the death occurs due to heartattacks and strokes which accounts for one third of premature death. CVD exhibitvarious signs in our body to alarm us by showing raise in blood pressure, diabetes,

cholesterol that leads to overweight and obesity. The main causative factors of CVDsare tobacco usage, alcohol abuse, unhealthy diet and inadequate physical activity.

InterventionIntervention

FATS AND CARBOHYDRATE INTAKE (Associations of fats andcarbohydrate intake withcardiovascular disease and mortalityin 18 countries fromFIVE CONTINENTS (PURE): APROSPECTIVE COHORT STUDY

Objective / outcome - To assess the association betweenfruit, vegetable and legume consumption andcardiovascular disease and mortality in 135,335 individualsin 18 countries.

Study design & type of prospective study - Prospectivecohort study Exposure: Country-specific, validated foodfrequency questionnaires Covariates: Demographics, otherlifestyle, health history, center Outcomes: Major CVD (CVdeath and nonfatal MI, stroke, and heart failure) (n=4784),using standardized definitions; total mortality (n=5796).

Population - Unbiased selection from general population in667 urban/rural communities in 18 countries N=135,335;aged 35-70 years, without CVD at baseline.

Contd.

Duration - Median 7.4 years

Data collection - Data were collected at the community, household, and individual levels.

Follow ups - Detailed follow-up to be done at 3, 6, and 9 years and repeated measures of selectedrisk factors, causes of death, other health outcomes, and community data to be collected.

Tools - Dietary intake of the individuals have to be recorded using validated food frequencyquestionnaires. . Standardised questionnaires used to collect information about demographicfactors, socioeconomic status (education, income, and employment), lifestyle (smoking, physicalactivity, and alcohol intake), health history, and medication use. Physical activity assessed usingthe International Physical Activity Questionnaire. Physical assessment included weight, height,waist and hip circumferences, and blood pressure.

Retrieval drop rate - Nil

InterventionIntervention

BLOOD PRESSUREAND CHOLESTEROL LEVELS

Objective / outcome - independent associations betweenyoung adult exposures to risk factors and later life CVD risk,accounting for later life exposures.

Study design & type of prospective study - the ARIC(Atherosclerosis Risk In Communities) study ; 2) the CARDIA(Cardiovascular Risk Development in Young Adults) study ; 3) theCHS study (Cardiovascular Health Study) ; 4) the FHS-O cohort(Framingham Heart Study Offspring Cohort) ; 5) the Health ABC(Health, Aging and Body Composition) study ; and 6) the MESAstudy (Multi-Ethnic Study of Atherosclerosis).

Contd.

Population - 36,030 individuals.

Duration - Adult life course

Data collection - Pooled data from multiple cohorts (which together span the adult life course),and leveraged the risk factor patterns observed in the younger cohorts to impute unobservedyoung adult exposures in the older cohorts.

Follow ups - From the cohorts

Tools - period-specific time-weighted averages (TWAs) of SBP, DBP, LDL, and HDL levels assummary measures of young (18 to 39 years of age) and later adult (≥40 years of age) exposuresto CVD risk factors.

Retrieval drop rate - Nil

Morning plasma cortisol as acardiovascular risk factor:findings from prospectivecohort and Mendelianrandomization studies inEuropean Journal ofEndocrinology

Objective / outcome - The identification of new causal riskfactors has the potential to improve cardiovascular disease(CVD) risk prediction and the development of new treatmentsto reduce CVD deaths. In the general population, we sought todetermine whether cortisol is a causal risk factor for CVD andcoronary heart disease (CHD).

Study design & type of prospective study - British Women’sHeart and Health Study (BWHHS) BWHHS is a prospectivecohort study of 4286 women who were randomly selectedfrom 23 British towns between 1999 and 2001 and who wereaged 60–79 years at baseline,multivariable regression in twoprospective nested case-control studies (total 798 participants,313 incident CVD/CHD with complete data).

Contd.

InterventionIntervention

Population - 4286 women

Duration - 3 years

Data collection - Serum cortisol levels were determined by radio-immunoassay (MPBiomedicals, UK; intra-assay CV 5.1–7.0%, inter-assay CV 6.0–7.9%) on blood samplesobtained at the baseline examination after a minimum 6-h fast between 08:00 h and 17:00 h.

Follow ups - At periodic regular intervals

Tools - Serum cortisol Retrieval drop rate- Nil

HEALTHY LIFESTYLE (CITATION) HEALTHY LIFESTYLEAND RISK OF HEART FAILURERESULTS FROM 2 PROSPECTIVECOHORT STUDIES SUSANNA ETAL

Objective / outcome - healthy lifestyle factors with HFincidence in 2 population-based prospective cohort studies.

Study design & type of prospective study - 33 966 men(Cohort of Swedish Men) and 30 713 women (SwedishMammography Cohort) who were 45 to 83 years of age andfree of HF and ischemic heart disease at baseline.

Population - Study population in the current analyses wereparticipants of the Cohort of Swedish Men (COSM) and theSwedish Mammography Cohort (SMC).

Duration - 13 years

Data collection - Incident HF cases were ascertained bylinkage with the Swedish National Patient Register and theSwedish Cause of Death Register. Cox proportional hazardsregression was used to analyze the data.

Contd.

InterventionIntervention

Follow ups - Information on smoking, weight, height, alcohol consumption, education,aspirin use, family history of myocardial infarction before 60 years of age, and history ofdiabetes mellitus, hypertension, and hypercholesterolemia was obtained by a self-administered questionnaire. Through linkage with the Swedish National Patient Register,we obtained information on diagnoses of atrial fibrillation and myocardial infarction.Participants were considered to have diabetes mellitus if they had a diagnosis ofdiabetes mellitus in the Swedish National Patient or Diabetes Registers or a self-reportof diabetes mellitus in the questionnaire. BMI was calculated from self-reported weightand height (kg/m2).

Tools - A healthy lifestyle was defined as being a nonsmoker and physically active (≥150min/wk), and having body mass index between 18.5 and 25 kg/m2 and a healthy diet(defined as adherence to a modified Mediterranean diet).

Retrieval drop rate - Nil

BEST-PRACTICEINTERVENTIONS IN BLOODPRESSURE,BLOOD GLUCOSEAND TOTALCHOLESTEROL (CITATION)

objective / outcome - (best-practice) interventions could reducesocioeconomic inequalities of coronary heart disease mortality.

Study design & type of prospective study - We undertook aprospective cohort study on 17 186 male civil servants aged 40–69 years between 1967 and 1970 in the UK (the Whitehall study).Socioeconomic position was based on employment grade.

Population - 19 019 non-industrial London-based malegovernment employees aged 40–69 years between Sept 14, 1967,and Jan 15, 1970 (response rate 74%).

Duration - 15 years

Contd.

InterventionIntervention

Data collection - A trained observer took a single blood-pressure reading from theparticipant's left arm with a London School of Hygiene sphygmomanometer. We recordedsystolic blood pressure at the first appearance of the Korotkoff sounds. We took a capillaryblood sample from the earlobe after an overnight fast. Participants then drank a 50-ganhydrous dextrose preparation. We measured plasma cholesterol concentration with thestandard Technicon method N24a, and we took a second blood sample 2 h later. We measuredpost-load blood glucose concentration by the ferricyanide reduction method on anautoanalyser.

Follow ups - 15-year mortality data were obtained from the National Health Service (NHS)Central Register with the NHS identifi cation number assigned to each citizen in the UK.

Tools - (reduction of systolic blood pressure by 10 mm Hg, of total cholesterol by 2 mmol/L,and of blood glucose by 1 mmol/L in pre-diabetic people; halving the prevalence of non-insulin-dependent diabetes; and complete cessation of cigarette smoking) or primordial prevention.

Retrieval drop rate - 3.7%

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This intervention also involved in screening fasting bloodspecimens, glucose, total cholesterol and high-densitylipoprotein (HDL) along with smoking status, medicationused and other necessary demographic variables can beobtained by questionnaire.

The primary outcome of this study can be estimated forcertain time line and will be compared with Framinghamrisk equations.

This equation helps in estimating the risk factors andcondition which involved in development of CVD(Maruthur, Wang, & Appel, 2009) The adherence towardsthe intervention should also been estimated foroptimizing the process.

ConclusionConclusion

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