Myocardial Infarction as the First Manifestation of Coronary Heart Disease: Rates of Heralded and Unheralded Myocardial Infarction

NCT01168869 | Completed DMC

• 2 other identifiers: CALIBER 09-07086091/Z/08/Z
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

Brief Summary

Some myocardial infarctions (MI) occur as the first manifestation of coronary artery disease. These are termed 'unheralded' events as they have not been preceded by other forms of coronary artery disease. Unheralded MIs are important because of the high likelihood of missed opportunities for prevention. The proportion of MIs that are 'unheralded' is unknown. This study aims to quantify the proportion of MIs that occur 'unheralded' and also give an estimate of the incidence of 'unheralded' MI in the UK, compared to 'heralded' MI and those with angina of recent onset (MIs with premonitory symptoms).

Conditions

Myocardial Infarction

Keywords

Manifestation; Coronary Heart Disease; Myocardial infarction; Angina pectoris; Unheralded; General Practice Research Database; Myocardial Ischaemia National Audit Project; CALIBER

Outcome Measures

Primary Outcomes (1)

• First myocardial infarction (MI)

  First MIs will be divided into three groups: (i) Those with previous manifestations of cardiovascular disease, diagnosed or treated more than 90 days before the MI. These are the 'Heralded MIs'. (ii) Those with a diagnosis or treatment of cardiovascular disease occurring only within 90 days before MI. These are the 'MIs with premonitory symptoms'. (iii) Those without any previous manifestation of cardiovascular disease at any time before MI. These are the 'Unheralded MIs'.

  Average time frame: patients in the GPRD are followed from registration until they experience the outcome, leave the practice, die, or 31st December 2009, whichever occurs first.

Study Arms (1)

GPRD patients

All patients included in "up to standard" GPRD practices that agreed to the linkage with the MINAP database are included in this cohort.

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 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 dataset.
• Age over 18.

You may not qualify if:

• Patients will be excluded after experiencing their first MI.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• British Medical Research Council: collaborator
• University College, London: collaborator

Study Sites (1)

London School of Hygiene and Tropical Medicine

London, WC1E 7HT, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Infarction; Coronary Disease; Angina Pectoris

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

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: Dr

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 23, 2010
• 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)