Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

Heart Failure Clinical Trial

Official title:

Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804439
• Other study ID #: CALIBER 12_153R
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: March 3, 2013
• Start date: January 1997
• Est. completion date: March 2010

Study information

• Verified date: March 2013
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardiovascular disease (CVD) is an important public health problem that affects millions of people worldwide. Associations between risk factors, such as smoking, dyslipidaemia or hypertension, and prevalent CVD are well documented. However, few studies have investigated associations with onset of disease. The initial manifestation of CVD, for example an episode of unstable angina, is important because it influences the prognosis, the quality of life and the management of disease. Furthermore, the extent to which social deprivation, alcohol consumption or atrial fibrillation affects presentation of CVD is poorly understood and deserves further consideration.

Most previous studies have considered CVD as a single entity. However, differences in aetiology between coronary phenotypes suggest that risk factors may not be shared across specific coronary phenotypes and their relative importance is likely to differ for each phenotype. Gaining knowledge of these differences could provide insights into the pathophysiology of specific forms of CVD and could eventually lead to modification of recommendations for patient management and disease prevention.

We propose to use the linkage of the national registry of coronary events to general practice records in the Clinical Practice Research Database (CPRD), to investigate whether demographic, behavioral, and clinico-metabolic risk factors differentially influence the onset of specific types of CVD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2240000
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Aged =30yrs old

• Registered in CPRD practices in England consenting to data linkage

• =1 year of up-to-standard pre-study follow-up

Exclusion Criteria:

• History of any of the CVD endpoints considered before study follow-up initiation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Acute Myocardial Infarction
• Aneurysm
• Angina Pectoris
• Angina, Stable
• Angina, Unstable
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Cardiac Arrest
• Cardiovascular Diseases
• Cerebrovascular Accident
• Chronic Stable Angina
• Death
• Death, Sudden
• Heart Arrest
• Heart Diseases
• Heart Failure
• Hemorrhage
• Infarction
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Myocardial Infarction
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Stroke
• Subarachnoid Hemorrhage
• Sudden Coronary Death
• Sudden Death
• Transient Ischemic Attack
• Unstable Angina
• Ventricular Arrhythmia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cardiovascular heart disease and fatal cardiovascular disease	Cardiovascular heart disease: combination of MI and unheralded coronary death. Cardiovascular disease: combination of fatal cardiovascular heart disease and stroke of any type.; Fatal cardiovascular disease: combination of fatal coronary heart disease and fatal cardiovascular death.	Same as for primary endpoint (maximum of 13 years after follow-up start)	No
Primary	First presentation of cardiovascular disease, as specified in description	First occurrence of the following fatal or non-fatal cardiovascular outcomes: acute myocardial infarction, unstable angina, stable angina, ischemic stroke, hemorrhagic stroke, subarachnoid hemorrhage, transient ischemic attack, abdominal aortic aneurysm, peripheral arterial disease, sudden cardiac death, heart failure	Study follow-up will commence on the earliest date on which a patient fulfils the criteria for study inclusion within the period between 1st January 1997 and 25th March 2010 (maximum of 13 years after enrolment).	No
Secondary	Non CVD specific deaths	Death from non CVD, that is, excluding deaths related to the primary endpoints.	Same as for primary outcomes (maximum of 13 years after follow-up start)	No