Cohort Descriptives

Variable Response
Cohort name PRIME (etude PRospective sur l'Infarctus du MyocardE)
Cohort acronym PRIME
General Study Overview The PRIME study was set up in 1991 as a prospective population-based study of risk factors which are associated with coronary heart disease and other cardiovascular disease such as stroke in middle aged men from Northern Ireland. In 2014 the PRIME study was awarded a grant by the British Heart Foundation to allow it to continue and complete the 10 year follow-up to identify whether periodontal (gum) disease at baseline was associated with new (incident) coronary heart disease events. The Cognitive Follow-Up Study began 2016 and involves an ACE-R cognitive test, a small blood sample, height, weight, waist and upper arm circumference measurements, handgrip strength and questionnaires about diet, overall health and dental health. Cognition was assessed once previously by an MMSE completed at a re-screening completed between 2001-2004. "
Number of subjects at baseline 2745
Institution name Queen's University Belfast, Institute of Clinical Sciences
Department name Centre for Public Health
City Belfast
Study or database website

http://www.qub.ac.uk/primestudy

Principal Investigator (PI): Name Professor Gerard Linden
PI: Address Queen’s University Belfast, Centre for Public Health, Institute of Clinical Sciences, Block B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BJ
PI: email

g.linden@qub.ac.uk

PI: phone 02890976101
Administrative Contact (AC): Name Bernadette McGuinness
AC: Address Queen’s University Belfast, Centre for Public Health, Institute of Clinical Sciences, Block B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BJ
AC: email B.mcguinness@qub.ac.uk
AC: phone +44 (0)28 9097 8959
Technical Contact/Data manager (TC): Name Angela Mullan
TC: Address Queen’s University Belfast, Centre for Public Health, Institute of Clinical Sciences, Block B, Royal Victoria Hospital, Grosvenor Road, Belfast, BT12 6BJ
TC: email

a.mullan@qub.ac.uk

TC: phone 02890976101
Key study references

Open literature list

Population based study? Yes
Family based study? No
Clinical based sample? Yes
Is there follow-up data available? Yes
Were participants included prior to development of dementia (may refer to controls only)? Yes
Were participants included prior to development of MCI (may refer to controls only)? Yes
How is data collected? In person
postal: A Baseline screening in the early nineties (1991-1993). A Rescreen between 2001-2004. 9 follow up postal questionnaires over the course of the cohort study.
Who carries out data collection? Interviewers
Clinical staff: Clerical staff collect questionnaire data. Research nurses staff collected physical data.
Does this take place in participants' homes or at a central location? Home
Central: Study included both home visits and hospital visits.
Do participants take part individually or are families/partners involved? Individually
Dementia cases ascertained as part of study: Yes
Diagnosis based on review of existing clinical data Yes
Was diagnosis/primary outcomes made blind to exposure variables? Yes
How regular is follow-up? Depends on funding which has been sought for different aspects of follow-up. To date principal focus has been on cardiovascular endpoints.Recent funding has focused on cognition.
Study start date 18/09/2017
Is study ongoing? Yes
Is study still recruiting? No
Inclusion criteria Representative sample of 50-60 year-old men living in Belfast area, Northern Ireland in early 1990's
Exclusion criteria None

Demographic and Clinical Information

Variable Response
Demographics
Age Yes
Age at time of diagnosis of dementia Yes: Cohort study of initially healthy men, dementia identified during recall/rescreening
Age at last follow-up Yes: Late 70's early 80's
Age at time of death Yes: Recorded as part of cohort study
Sex Yes
Ethnicity Yes
Education Yes
Physical examinations
Any physical examination performed? Yes
Blood pressure Data available
Weight Data available
Height Data available
Heart Rate Data available
ECG Data available
Specify any others Respiratory function
Medical conditions
Cardiovascular disease data Yes
Myocardial infarction Data available
Medication use for CVD Data available
Hypertension Data available
Systolic/diastolic BP Data available
Hypotension Data available
Hypercholesterolemia Yes
Medication use Yes
Cancer Data available
Diabetic Status Data available

Cognitive Outcomes

Variable Response
Any domain-specific cognitive test performed? Yes
IQ data available? No
NART No
Cognitive background? Yes
Years of education Yes
Level of education Yes
Parental education No
Standard dementia global cognition scales? Yes
MMSE Yes
MoCA No
ADAS-Cog No
Addenbrooke's Cognitive Exam No
3MS No
GPCOG No

Non-Cognitive Clinical Outcomes

Variable Response
Dementia diagnosis
Functional rating scales
Health service utilisation
Any Health Resource Utilisation Collected ? Yes
Hospital utilisation Yes
Permanent stay at nursing home Yes
Informal ADL care Yes
Informal iADL care Yes
Other neurological or psychiatric measurements? Yes
Any stroke data? Yes
Stroke type Yes
Transient Ischemic Attack Yes
Any head trauma data? No

Imaging

Variable Response
For imaging data, what format(s) do you use for storing data? N/A

Genetics

Variable Response
Overview
Gene screening

Biological samples

Variable Response
Blood collected Yes
Plasma Yes
Serum Yes
RNA No
DNA Yes
Abeta 1-40 No
Abeta 1-42 No
Abeta x-40 No
Abeta x-42 No
Blood Metabolic Analytes
CRP (c-reactive protein) Yes
eGFR (estimated Glomular Filtration Rate) No
Glucose No
HbA1c No
Lipids Yes
Liver Function Tests No
Serum creatinine Yes
Homocysteine No
Folate No
Other blood samples No
Are laboratory protocols and storage information available for bloods Yes
Urine collection
Urine No
Autopsy data
Autopsy Yes
Saliva
Saliva collected No
Cortisol No
Are laboratory protocols and saliva storage information available? No
CSF
CSF collected No
CSF Abeta No
CSF tau No
No
Are CSF laboratory protocols and storage information available? No
Mitochondrial function Comments
mtDNA abnormalities No
Oxidative stress No

Brain donation

Variable Response
Is brain donation part of the existing protocol? No

Lifestyle

Variable Response
Smoking Yes
Pack years Data available
Current smoking Data available
Former smoking Data available
Alcohol Data available
Units per day/week vs weekend Data available
Specified beverage type (wine, spirits, beers) Data available
Abstainers/former users Data available
Alcohol Use Disorders Identification Test (AUDIT) or other screen instrument (name) Data available
Binge drinking Data available
Drugs of abuse assessment
Obesity and associated risk factors
BMI Data available
Blood lipids Data available
Physical activity and exercise Yes
Type of exercise: heavy, light Data available
Exercise duration Data available
Diet Yes
Carbs, protein, fats, fish oil Data available
Anti-oxidants Data available
Vegetarian? Data available
Food questionnaires Data available
Employment status
Employment status Data available
Living situation
Living situation Data available
Socioeconomic status
Socioeconomic status measures Data available
Sleep assessment

Ethics and Engagement

Variable Response
Participant engagement
Is there participant representation in the governance of the cohort? No
Do existing mechanisms for consulting/involving participants exist? No
If so, does this happen on an ongoing or an ad hoc basis? N/A
Ethics
Is there an ethics advisory or ELSI group within the cohort governance? No
If yes, who is represented on it? N/A
Does the cohort include participants who lack capacity? Yes
Is there a process in place for participants who lose capacity? Yes
Do participants provide contact information for a person to act as a potential consultee? No
Disclosure
Do procedures exist for the disclosure of incidental findings? No
What kinds of finding do these relate to? (imaging, genotyping, etc) N/A
Who is responsible for disclosing incidental findings? N/A
Do procedures exist for the disclosure of clinically relevant information identified as a direct focus of the study? (e.g. a diagnosis of dementia) No
Recruitment
How was the cohort recruited (NHS or not, primary or secondary care)? Representative sample of male population
Does the study involve ongoing connections with participants' own doctors (e.g. GPs)? Yes
Consent and recontact
Is there consent for recontact? Yes
If so, under what conditions? For further follow-up

Data Management

Variable Response
Consent for linkage to routine data