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Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01804439
First Posted: March 5, 2013
Last Update Posted: March 5, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Harry Hemingway, University College, London
  Purpose

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.


Condition
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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Cardiovascular Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes: a CALIBER Proposal Using Linked GPRD-MINAP-HES Data

Resource links provided by NLM:


Further study details as provided by Harry Hemingway, University College, London:

Primary Outcome Measures:
  • 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). ]
    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


Secondary Outcome Measures:
  • Non CVD specific deaths [ Time Frame: Same as for primary outcomes (maximum of 13 years after follow-up start) ]
    Death from non CVD, that is, excluding deaths related to the primary endpoints.


Other Outcome Measures:
  • Cardiovascular heart disease and fatal cardiovascular disease [ Time Frame: Same as for primary endpoint (maximum of 13 years after follow-up start) ]

    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.



Enrollment: 2240000
Study Start Date: January 1997
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harry Hemingway, Professor Harry Hemingway, University College, London
ClinicalTrials.gov Identifier: NCT01804439     History of Changes
Other Study ID Numbers: CALIBER 12_153R
First Submitted: January 8, 2013
First Posted: March 5, 2013
Last Update Posted: March 5, 2013
Last Verified: March 2013

Keywords provided by Harry Hemingway, University College, London:
Brain diseases
Arteriosclerosis
Heart diseases
Cardiovascular diseases
Coronary heart disease not otherwise specified
Cerebrovascular disorders
Central nervous system diseases
Nervous system diseases
Atherosclerosis
Pathologic processes
Acute myocardial infarction
Myocardial infarction
Myocardial ischemia
Infarction
Necrosis
Unstable angina
Chronic stable angina
Stable angina
Angina pectoris
Chest pain
Pain
Signs and symptoms
Ischemia
Ischemic stroke
Hemorrhagic stroke
Stroke
Subarachnoid hemorrhage
Transient ischemic attack
Abdominal aortic aneurysm
Aneurysm

Additional relevant MeSH terms:
Brain Diseases
Arteriosclerosis
Brain Ischemia
Stroke
Heart Failure
Ischemia
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Hemorrhage
Aneurysm
Angina Pectoris
Death
Heart Arrest
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Subarachnoid Hemorrhage
Aortic Aneurysm, Abdominal
Angina, Stable
Ischemic Attack, Transient
Angina, Unstable
Death, Sudden
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Pathologic Processes
Necrosis