Mersey Acute Coronary Syndrome Rule-Out Using High Sensitive Troponin

NCT02581540 | Completed

• 1 other identifier: 808/15
• Study Type: observational
• Target: 3,054
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this observational study is twofold. The primary hypothesis being tested is that initial(first) high sensitivity Tn \<5ng/l (limit of detection) combined with an ECG with no ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI score (\<2), GRACE \<75 and HEART score ≤ 3. (Hs tn T- Roche elecsys HS tn T) and also against HS troponin at the 99th percentile (\<15ng/l with nonischaemic changes)- again all scored with initial (first tn ) only. The second aim is to directly compare the three established methods of risk stratifying patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the era of high sensitivity troponins performs best.

Conditions

Acute Coronary Syndrome; Angina Pectoris; Cardiovascular Diseases; Chest Pain; Heart Diseases; Myocardial Ischemia; Heart Attack; Chest Pain Atypical Syndrome; Angina, Unstable; Myocardial Infarction

Keywords

Troponin; High Sensitivity Troponin T; MACE; risk stratification; suspected cardiac chest pain; Acute Coronary Syndrome; GRACE; TIMI; HEART

Outcome Measures

Primary Outcomes (1)

• Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation at 1 year

  To compare the observed versus predicted incidence of major adverse cardiovascular events (MACE) amongst the three methods of risk stratifications (GRACE, TIMI, HEART) at 1 year in order to determine the most effective risk score

  12 months observational period from recruitment date

Secondary Outcomes (1)

• Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation ; in patients with a normal ECG/initial Troponin

  12 months observational period from recruitment date

Study Arms (1)

Suspected Cardiac Chest Pain

This cohort is observed for the incidence of MACE (death, non-fatal myocardial infarction and emergency revascularisation)

Eligibility Criteria

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

Study Population

Patients presenting to the emergency department at a single large teaching hospital- Aintree University Hospital, Merseyside between June 2011 and November 2011 with suspected cardiac chest pain

You may qualify if:

• All patients aged \>18 years presenting to the emergency department at Aintree University Hospital,Merseyside between June-November 2011 with suspected cardiac chest pain

You may not qualify if:

• The presence of a definitive non-ischaemic cause for chest pain, trauma-related chest pain, cardiac arrest on arrival to the ED.
• Patients without HS troponin T which indicates no suspicion of a cardiac cause of chest pain

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Related Publications (1)

• Khand A, Frost F, Grainger R, Fisher M, Chew P, Mullen L, Patel B, Obeidat M, Albouaini K, Dodd J. Identification of high-risk non-ST elevation myocardial infarction at presentation to emergency department. A prospective observational cohort study in North West England. BMJ Open. 2020 Jun 8;10(6):e030128. doi: 10.1136/bmjopen-2019-030128.

  PMID: 32518208 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina Pectoris; Cardiovascular Diseases; Chest Pain; Heart Diseases; Myocardial Ischemia; Myocardial Infarction; Angina, Unstable

Condition Hierarchy (Ancestors)

Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Aleem Khand, MbChB,MRCP

  Aintree University Hospital NHS Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: October 21, 2015
• Study Start: June 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: September 9, 2021

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share