Natural Ischaemic Preconditioning Before First Myocardial Infarction
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Purpose
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.
| Condition |
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Myocardial Infarction Angina Pectoris Coronary Heart Disease Peripheral Arterial Disease Cerebrovascular Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | 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 |
- Recurrent myocardial infarction [ Time Frame: Up to seven years ] [ Designated as safety issue: No ]Myocardial infarction occurring thirty or more days after the study start date.
- Coronary mortality [ Time Frame: Up to seven years ] [ Designated as safety issue: No ]Coronary mortality, using ONS mortality statistics (ICD-10 codes I20-I25)
| Estimated Enrollment: | 13000 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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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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Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The study population is comprised of patients with a first myocardial infarction who are registered at those GPRD practices that agreed to the linkage with the MINAP database, and whose practices are "up to standard" according to GPRD criteria. Practices taking part in the GPRD are chosen to be representative of all UK practices, and 98% of people in the UK are registered with a GP. Therefore the GPRD should be a representative sample of the UK population.
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.
Contacts and Locations| United Kingdom | |
| London School of Hygiene and Tropical Medicine | |
| London, United Kingdom, WC1E 7HT | |
| Principal Investigator: | Emily Herrett, MSc | London School of Hygiene and Tropical Medicine |
| Study Director: | Harry Hemingway, FRCP | University College, London |
More Information
Additional Information:
No publications provided
| Responsible Party: | Emily Herrett, Research Degree Student, London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01604486 History of Changes |
| Other Study ID Numbers: | EH CALIBER IP, 086091/Z/08/Z |
| Study First Received: | May 21, 2012 |
| Last Updated: | May 23, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by London School of Hygiene and Tropical Medicine:
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Myocardial infarction Ischaemic preconditioning Myocardial Ischaemia National Audit Project |
General Practice Research Database Hospital Episode Statistics Office for National Statistics |
Additional relevant MeSH terms:
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Angina Pectoris Cerebrovascular Disorders Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Infarction Myocardial Infarction Peripheral Arterial Disease Peripheral Vascular Diseases Acute Coronary Syndrome Cardiovascular Diseases Vascular Diseases |
Chest Pain Pain Signs and Symptoms Brain Diseases Central Nervous System Diseases Nervous System Diseases Arteriosclerosis Arterial Occlusive Diseases Ischemia Pathologic Processes Necrosis Atherosclerosis |
ClinicalTrials.gov processed this record on May 23, 2013