Natural Ischaemic Preconditioning Before First Myocardial Infarction

Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604486
• Other study ID #: EH CALIBER IP
• Secondary ID: 086091/Z/08/Z
• Status: Completed
• Phase: N/A
• First received: May 21, 2012
• Last updated: October 1, 2015
• Start date: September 2009
• Est. completion date: December 2013

Study information

• Verified date: October 2015
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16000
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Angina Pectoris
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
United Kingdom	London School of Hygiene and Tropical Medicine	London

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent myocardial infarction	Myocardial infarction occurring thirty or more days after the study start date.	Up to seven years	No
Secondary	Coronary mortality	Coronary mortality, using ONS mortality statistics (ICD-10 codes I20-I25)	Up to seven years	No