Natural Ischaemic Preconditioning Before First Myocardial Infarction

NCT01604486 | Completed DMC

• 2 other identifiers: EH CALIBER IP086091/Z/08/Z
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction; Angina Pectoris; Coronary Heart Disease; Peripheral Arterial Disease; Cerebrovascular Disease

Keywords

Myocardial infarction; Ischaemic preconditioning; Myocardial Ischaemia National Audit Project; General Practice Research Database; Hospital Episode Statistics; Office for National Statistics

Outcome Measures

Primary Outcomes (1)

• Recurrent myocardial infarction

  Myocardial infarction occurring thirty or more days after the study start date.

  Up to seven years

Secondary Outcomes (1)

• Coronary mortality

  Up to seven years

Study Arms (4)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• University College, London: collaborator

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

Related Publications (1)

• Herrett E, Bhaskaran K, Timmis A, Denaxas S, Hemingway H, Smeeth L. Association between clinical presentations before myocardial infarction and coronary mortality: a prospective population-based study using linked electronic records. Eur Heart J. 2014 Sep 14;35(35):2363-71. doi: 10.1093/eurheartj/ehu286. Epub 2014 Jul 19.

  PMID: 25038774 DERIVED

MeSH Terms

Conditions

Myocardial Infarction; Angina Pectoris; Coronary Disease; Peripheral Arterial Disease; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Emily Herrett, MSc

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Harry Hemingway, FRCP

  University College, London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Degree Student

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: September 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

GB (1)