Natural Ischaemic Preconditioning Before First Myocardial Infarction
|ClinicalTrials.gov Identifier: NCT01604486|
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : October 2, 2015
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 or disease|
|Myocardial Infarction Angina Pectoris Coronary Heart Disease Peripheral Arterial Disease Cerebrovascular Disease|
|Study Type :||Observational|
|Actual Enrollment :||16000 participants|
|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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
MI without ischaemic preconditioning
Myocardial infarction unheralded by any previous cardiovascular disease diagnosis and without symptoms of chest pain in the previous 90 days.
MI with longstanding disease
Patients with myocardial infarction who have had diagnosed atherosclerotic disease for longer than 90 days preceding infarct.
MI with only chest pain
Patients with chest pain in the 90 days preceding MI, but with no prior atherosclerotic disease diagnoses.
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.
- Recurrent myocardial infarction [ Time Frame: Up to seven years ]Myocardial infarction occurring thirty or more days after the study start date.
- Coronary mortality [ Time Frame: Up to seven years ]Coronary mortality, using ONS mortality statistics (ICD-10 codes I20-I25)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01604486
|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|