Natural Ischaemic Preconditioning Before First Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01604486
Recruitment Status : Completed
First Posted : May 23, 2012
Last Update Posted : October 2, 2015
University College, London
Information provided by (Responsible Party):
Emily Herrett, London School of Hygiene and Tropical Medicine

Brief Summary:

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
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
Study Start Date : September 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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.

Primary Outcome Measures :
  1. Recurrent myocardial infarction [ Time Frame: Up to seven years ]
    Myocardial infarction occurring thirty or more days after the study start date.

Secondary Outcome Measures :
  1. Coronary mortality [ Time Frame: Up to seven years ]
    Coronary mortality, using ONS mortality statistics (ICD-10 codes I20-I25)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01604486

United Kingdom
London School of Hygiene and Tropical Medicine
London, United Kingdom, WC1E 7HT
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University College, London
Principal Investigator: Emily Herrett, MSc London School of Hygiene and Tropical Medicine
Study Director: Harry Hemingway, FRCP University College, London

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Emily Herrett, Research Degree Student, London School of Hygiene and Tropical Medicine Identifier: NCT01604486     History of Changes
Other Study ID Numbers: EH CALIBER IP
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust )
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015

Keywords provided by Emily Herrett, London School of Hygiene and Tropical Medicine:
Myocardial infarction
Ischaemic preconditioning
Myocardial Ischaemia National Audit Project
General Practice Research Database
Hospital Episode Statistics
Office for National Statistics

Additional relevant MeSH terms:
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Angina Pectoris
Cerebrovascular Disorders
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases