Natural Ischaemic Preconditioning Before First Myocardial Infarction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Emily Herrett, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01604486
First received: May 21, 2012
Last updated: May 23, 2012
Last verified: May 2012
  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
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

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604486

Locations
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
Investigators
Principal Investigator: Emily Herrett, MSc London School of Hygiene and Tropical Medicine
Study Director: Harry Hemingway, FRCP University College, London
  More 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:
Myocardial infarction
Ischaemic preconditioning
Myocardial Ischaemia National Audit Project
General Practice Research Database
Hospital Episode Statistics
Office for National Statistics

Additional relevant MeSH terms:
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 April 20, 2014