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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
  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 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). ] [ 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


Secondary Outcome Measures:
  • 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.


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) ] [ 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.



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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Harry Hemingway, Professor Harry Hemingway, University College, London
ClinicalTrials.gov Identifier: NCT01804439     History of Changes
Other Study ID Numbers: CALIBER 12_153R
Study First Received: January 8, 2013
Last Updated: March 3, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by University College, London:
Heart diseases
Cardiovascular diseases
Coronary heart disease not otherwise specified
Cerebrovascular disorders
Brain diseases
Central nervous system diseases
Nervous system diseases
Atherosclerosis
Arteriosclerosis
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:
Aneurysm
Angina Pectoris
Angina, Stable
Angina, Unstable
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Cardiovascular Diseases
Cerebral Infarction
Death
Death, Sudden
Heart Arrest
Heart Diseases
Heart Failure
Hemorrhage
Infarction
Ischemia
Ischemic Attack, Transient
Myocardial Infarction
Peripheral Arterial Disease
Peripheral Vascular Diseases
Stroke
Subarachnoid Hemorrhage
Aortic Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Brain Diseases
Brain Infarction
Brain Ischemia
Central Nervous System Diseases

ClinicalTrials.gov processed this record on November 20, 2014