- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02424994
Morbidity and Mortality in Patients With Hypertrophic Cardiomyopathy: a CALIBER Study (HCM)
Morbidity and Mortality in Patients Diagnosed With Hypertrophic Cardiomyopathy: a CALIBER Study
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Most data on hypertrophic cardiomyopathy related morbidity and mortality are derived primarily from longitudinal, observational studies based at tertiary cardiac centres. It is unclear what the main causes of morbidity and death are in the general hypertropic cardiomyopathy population (outside tertiary referral centres) and it is likely that many patients have a benign clinical course and die from non-cardiac causes.
Linkage of the Clinical Practice Research Datalink (CPRD) to the Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office of National Statistics (ONS), offers the opportunities to study the natural history of hypertrophic cardiomyopathy, from the time of diagnosis to the end of life, health care utilisation and to investigate the association between clinical characteristics and common clinical fatal and non-fatal outcomes.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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London, Storbritannien, NW1 2DA
- University College London Farr Institute of Health Informatics Research
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- One year or more of follow-up in the practice prior to study entry
- 18 years or older
Exclusion Criteria:
• Unknown sex and age
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Rate ratios for the associations between hypertrophic cardiomyopathy and angina
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Rate ratios for the associations between hypertrophic cardiomyopathy and unstable angina
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and myocardial infarction
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and cardiac arrest
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and ventricular arrhythmia
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and atrial fibrillation
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and heart failure
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and transient ischemic attack
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and stroke
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
|
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Rate ratios for the associations between hypertrophic cardiomyopathy and peripheral arterial disease
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Rate ratios for the associations between hypertrophic cardiomyopathy and abdominal aortic aneurysm
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Rate ratios for the associations between hypertrophic cardiomyopathy and systemic thromboembolism
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Rate ratios for the associations between hypertrophic cardiomyopathy and cancer
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Rate ratios for the associations between hypertrophic cardiomyopathy and chronic obstructive pulmonary disease
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Rate ratios for the associations between hypertrophic cardiomyopathy and liver-related
Tidsram: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 13_096R
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