- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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London, Regno Unito, WC1E 7HT
- London School of Hygiene and Tropical Medicine
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Recurrent myocardial infarction
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Coronary mortality
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Ischemia
- Processi patologici
- Necrosi
- Ischemia miocardica
- Malattia cardiovascolare
- Malattie vascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Arteriosclerosi
- Malattie arteriose occlusive
- Dolore
- Manifestazioni neurologiche
- Aterosclerosi
- Dolore al petto
- Infarto miocardico
- Infarto
- Malattie cardiache
- Malattia coronarica
- Malattia arteriosa periferica
- Malattie vascolari periferiche
- Angina pectoris
- Disturbi cerebrovascolari
Altri numeri di identificazione dello studio
- EH CALIBER IP
- 086091/Z/08/Z (Altro numero di sovvenzione/finanziamento: Wellcome Trust)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .