- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01604486
Natural Ischaemic Preconditioning Before First Myocardial Infarction
Natural Ischaemic Preconditioning Before First Myocardial Infarction: an Analysis of Prospectively Collected UK Electronic Primary Care Records Linked to the National Registry of Acute Coronary Syndromes
There is a sharp rise in the rate of coronary heart disease diagnoses and chest pain consultations in the 90 days before a first heart attack. There is some evidence that chest pain and angina symptoms in this period have a beneficial effect on heart attack outcomes in hospital and shortly after discharge. However, the available evidence is lacking in three key areas. First it is based on a retrospective patient report of symptoms after the heart attack has occurred; this means that patients are required to survive their heart attack and may make errors when reporting prior symptoms. Second, evidence for an effect on longer term outcomes, and coronary outcomes in particular (e.g. coronary death, further heart attacks) are unknown. Third, there is conflicting evidence that these effects might differ by age, in men and women, and according to treatment in hospital.
The investigators hope to address the limitations in the evidence by performing a large, prospective study of the occurrence, timing and effect of different types of symptoms and disease diagnoses occurring before heart attack.
The investigators hypothesise that prospectively collected, clinical measures of chest pain symptoms and cardiovascular diagnoses in primary care will have a beneficial effect on short term coronary mortality and may have a beneficial effect on longer term coronary outcomes.
Studieöversikt
Status
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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London, Storbritannien, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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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:
- Patients in GPRD practices which are deemed "up to standard" by GPRD criteria will be included if their practice agreed to be linked to the MINAP, HES and ONS datasets.
- Patients must have at least one year of GPRD "up to standard" registration before the date of first MI.
- Age over 18.
- First myocardial infarction occurring between 1st January 2003 and 31st December 2008, as recorded in the Hospital Episode Statistics data or the Myocardial Ischaemia National Audit Project.
Exclusion Criteria:
- Patients will be excluded if they do not fulfil one of the inclusion criteria.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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MI without ischaemic preconditioning
Myocardial infarction unheralded by any previous cardiovascular disease diagnosis and without symptoms of chest pain in the previous 90 days.
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MI with longstanding disease
Patients with myocardial infarction who have had diagnosed atherosclerotic disease for longer than 90 days preceding infarct.
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MI with only chest pain
Patients with chest pain in the 90 days preceding MI, but with no prior atherosclerotic disease diagnoses.
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MI with disease and chest pain
Myocardial infarction occurring with previously diagnosed atherosclerotic disease of longer than 90 days' duration, but with chest pain in 90 days preceding infarct.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Recurrent myocardial infarction
Tidsram: Up to seven years
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Myocardial infarction occurring thirty or more days after the study start date.
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Up to seven years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Coronary mortality
Tidsram: Up to seven years
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Coronary mortality, using ONS mortality statistics (ICD-10 codes I20-I25)
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Up to seven years
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Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
Nyckelord
Ytterligare relevanta MeSH-villkor
- Ischemi
- Patologiska processer
- Nekros
- Myokardischemi
- Hjärt-kärlsjukdomar
- Kärlsjukdomar
- Hjärnsjukdomar
- Sjukdomar i centrala nervsystemet
- Sjukdomar i nervsystemet
- Arterioskleros
- Arteriella ocklusiva sjukdomar
- Smärta
- Neurologiska manifestationer
- Åderförkalkning
- Bröstsmärta
- Hjärtinfarkt
- Infarkt
- Hjärtsjukdom
- Kranskärlssjukdom
- Perifer arteriell sjukdom
- Perifera vaskulära sjukdomar
- Angina pectoris
- Cerebrovaskulära störningar
Andra studie-ID-nummer
- EH CALIBER IP
- 086091/Z/08/Z (Annat bidrag/finansieringsnummer: Wellcome Trust)
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