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Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Harry Hemingway, University College, London
ClinicalTrials.gov Identifier:
NCT01804439
First received: January 8, 2013
Last updated: March 3, 2013
Last verified: March 2013

January 8, 2013
March 3, 2013
January 1997
March 2010   (final data collection date for primary outcome measure)
First presentation of cardiovascular disease, as specified in description [ Time Frame: 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). ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01804439 on ClinicalTrials.gov Archive Site
Non CVD specific deaths [ Time Frame: Same as for primary outcomes (maximum of 13 years after follow-up start) ] [ Designated as safety issue: No ]
Death from non CVD, that is, excluding deaths related to the primary endpoints.
Same as current
Cardiovascular heart disease and fatal cardiovascular disease [ Time Frame: Same as for primary endpoint (maximum of 13 years after follow-up start) ] [ Designated as safety issue: No ]

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

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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
10 Years
Not Provided
Non-Probability Sample

The study population will include all patients aged ≥30yrs old, registered in CPRD practices in England consenting to data linkage, with at least 1 year of up-to-standard pre-study follow-up and no history of any of the CVD endpoints considered. Follow-up for endpoints will commence on the earliest date on which a patient fulfils the criteria, within the period between 1st January 1997 and 25th March 2010.

  • Heart Diseases
  • Cardiovascular Diseases
  • Acute Myocardial Infarction
  • Unstable Angina
  • Chronic Stable Angina
  • Ischemic Stroke
  • Cerebrovascular Accident
  • Subarachnoid Hemorrhage
  • Transient Ischemic Attack
  • Abdominal Aortic Aneurysm
  • Peripheral Arterial Disease
  • Sudden Coronary Death
  • Ventricular Arrhythmia
  • Sudden Death
  • Cardiac Arrest
  • Heart Failure
Not Provided
CALIBER Healthy Cohort
We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database [GPRD]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2240000
March 2010
March 2010   (final data collection date for primary outcome measure)

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.
Both
30 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01804439
CALIBER 12_153R
No
Harry Hemingway, University College, London
University College, London
Not Provided
Not Provided
University College, London
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP