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K GRACE Risk Score Intervention Study

Phase 3
Completed
Conditions
Acute coronary syndrome (ACS)
Circulatory System
Registration Number
ISRCTN29731761
Lead Sponsor
niversity of Leeds
Brief Summary

2019 Protocol article in https://bmjopen.bmj.com/content/9/9/e032165.info (added 12/08/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37315959/ (added 15/06/2023)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
3050
Inclusion Criteria

Research sites inclusion criteria:
1. Acute hospital participating in MINAP
2. Willing to implement the GRACE risk score tool

Patient inclusion criteria:
1. Age greater than or equal to 18 (no upper age limit)
2. Symptoms consistent with acute cardiac ischaemia for >10mins within 24 hours of presentation to hospital
3. One of the following and/or at least two of the High Risk Features:
3.1. ECG changes:
3.1.1. Transient ST-segment elevation of 0.5mm in 2 or more contiguous leads;
3.1.2. ST-segment depression of 0.5mm in 2 or more contiguous leads;
3.1.3. New T wave inversion of 1 mm in 2 or more contiguous leads;
3.1.4. New Q waves [1/3 height of R wave or >0.04 seconds];
3.1.5. New R wave > S wave in lead V1; or,
3.1.6. New left bundle branch block
3.2. Elevated cardiac biomarkers:
3.2.1. Troponin T or I above the upper reference limit (URL);
3.2.2. CK-MB 2x URL; or,
3.2.3. If there is no CK-MB available, then total CK greater than the local URL
3.3. Documented coronary artery disease:
3.3.1. History of MI or angina;
3.3.2. Congestive cardiac failure due to ischaemia;
3.3.3. Resuscitated sudden cardiac death;
3.3.4. Prior or new positive stress test with or without imaging;
3.3.5. Prior or new, cardiac catheterisation, percutaneous coronary artery intervention or coronary artery bypass graft surgery documenting coronary artery disease
3.4. At least 2 of the following High Risk features:
3.4.1. Haemodynamic compromise (SBP <90 mmHg and HR >100 bpm)
3.4.2. Left ventricular systolic dysfunction (LVEF <0.40);
3.4.3. Presence of known diabetes mellitus
3.4.4. Documentation of chronic kidney disease (estimated GFR <60mls/min/m2)
4. Willing and able to provide written informed consent

Exclusion Criteria

Research sites exclusion criteria:
GRACE risk tool already implemented.

Patient exclusion criteria:
1. Patients presenting at hospital due to an acute ST-segment elevation myocardial infarction (STEMI)
2. Patients presenting at hospital with an ACS accompanied with, or precipitate by significant co-morbidity e.g. motor vehicle accident, trauma, severe gastrointestinal bleeding
3. Peri-operative or peri-procedural MI
4. Patients already recruited into the study

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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