Optimum Troponin Cutoffs for ACS in the ED

NCT01994577 | Completed

• 1 other identifier: ROMI-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Blood tests may be able to quickly identify and exclude patients that are having a heart attack. Using these tests in the Emergency Department (ED) may lead to faster treatment, a reduced wait time, and quicker discharge for patients presenting with symptoms suggestive of a heart attack.

Conditions

Acute Coronary Syndrome (ACS)

Keywords

Emergency Department; Cardiac troponin; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Composite Outcome

  We have chosen a composite outcome that includes cardiovascular death, MI, serious ventricular cardiac dysrhythmia, hospital admission for decompensated congestive heart failure, and hospital admission for refractory cardiac ischemia following ED discharge at 7, 30 and 180 days based on our understanding and previous assessment of the strengths and limitations of composite endpoints, expert consensus opinion and our previous biomarker research.

  7, 30, and 180 days

Study Arms (1)

Adults (18+) presenting to the ED with symptoms of ACS

Eligibility Criteria

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

Study Population

Adult residents presenting to any of three EDs in Hamilton, Ontario

You may qualify if:

• years of age or older
• Presenting to any of three EDs in Hamilton, Ontario
• Chief complaint of suspected symptoms of acute coronary syndrome

You may not qualify if:

• Patients with any component of a composite outcome that includes cardio-vascular death, MI, serious ventricular cardiac dysrhythmia, decompensated congestive heart failure requiring hospital admission and hospital admission for refractory cardiac ischemia that occur prior to the initial blood sample being drawn will be excluded.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (7)

• Kavsak PA, Cerasuolo JO, Ko DT, Ma J, Sherbino J, Mondoux SE, Clayton N, Hill SA, McQueen M, Griffith LE, Mehta SR, Perez R, Seow H, Devereaux PJ, Worster A. Using the clinical chemistry score in the emergency department to detect adverse cardiac events: a diagnostic accuracy study. CMAJ Open. 2020 Nov 2;8(4):E676-E684. doi: 10.9778/cmajo.20200047. Print 2020 Oct-Dec.

  PMID: 33139388 DERIVED

• Neumann JT, Twerenbold R, Ojeda F, Sorensen NA, Chapman AR, Shah ASV, Anand A, Boeddinghaus J, Nestelberger T, Badertscher P, Mokhtari A, Pickering JW, Troughton RW, Greenslade J, Parsonage W, Mueller-Hennessen M, Gori T, Jernberg T, Morris N, Liebetrau C, Hamm C, Katus HA, Munzel T, Landmesser U, Salomaa V, Iacoviello L, Ferrario MM, Giampaoli S, Kee F, Thorand B, Peters A, Borchini R, Jorgensen T, Soderberg S, Sans S, Tunstall-Pedoe H, Kuulasmaa K, Renne T, Lackner KJ, Worster A, Body R, Ekelund U, Kavsak PA, Keller T, Lindahl B, Wild P, Giannitsis E, Than M, Cullen LA, Mills NL, Mueller C, Zeller T, Westermann D, Blankenberg S; COMPASS-MI Study Group. Application of High-Sensitivity Troponin in Suspected Myocardial Infarction. N Engl J Med. 2019 Jun 27;380(26):2529-2540. doi: 10.1056/NEJMoa1803377.

  PMID: 31242362 DERIVED

• Kavsak PA, Neumann JT, Cullen L, Than M, Shortt C, Greenslade JH, Pickering JW, Ojeda F, Ma J, Clayton N, Sherbino J, Hill SA, McQueen M, Westermann D, Sorensen NA, Parsonage WA, Griffith L, Mehta SR, Devereaux PJ, Richards M, Troughton R, Pemberton C, Aldous S, Blankenberg S, Worster A. Clinical chemistry score versus high-sensitivity cardiac troponin I and T tests alone to identify patients at low or high risk for myocardial infarction or death at presentation to the emergency department. CMAJ. 2018 Aug 20;190(33):E974-E984. doi: 10.1503/cmaj.180144.

  PMID: 30127037 DERIVED

• Kavsak PA, Worster A, Shortt C, Ma J, Clayton N, Sherbino J, Hill SA, McQueen M, Griffith L, Mehta SR, Devereaux PJ. High-sensitivity cardiac troponin concentrations at emergency department presentation in females and males with an acute cardiac outcome. Ann Clin Biochem. 2018 Sep;55(5):604-607. doi: 10.1177/0004563217743997. Epub 2017 Nov 23.

  PMID: 29169258 DERIVED

• Kavsak PA, Worster A, Ma J, Shortt C, Clayton N, Sherbino J, Hill SA, McQueen M, Mehta SR, Devereaux PJ. High-Sensitivity Cardiac Troponin Risk Cutoffs for Acute Cardiac Outcomes at Emergency Department Presentation. Can J Cardiol. 2017 Jul;33(7):898-903. doi: 10.1016/j.cjca.2017.04.011. Epub 2017 May 3.

  PMID: 28668141 DERIVED

• Kavsak PA, Shortt C, Ma J, Clayton N, Sherbino J, Hill SA, McQueen M, Mehta SR, Devereaux PJ, Worster A. A laboratory score at presentation to rule-out serious cardiac outcomes or death in patients presenting with symptoms suggestive of acute coronary syndrome. Clin Chim Acta. 2017 Jun;469:69-74. doi: 10.1016/j.cca.2017.03.021. Epub 2017 Mar 23.

  PMID: 28342713 DERIVED

• Shortt C, Ma J, Clayton N, Sherbino J, Whitlock R, Pare G, Hill SA, McQueen M, Mehta SR, Devereaux PJ, Worster A, Kavsak PA. Rule-In and Rule-Out of Myocardial Infarction Using Cardiac Troponin and Glycemic Biomarkers in Patients with Symptoms Suggestive of Acute Coronary Syndrome. Clin Chem. 2017 Jan;63(1):403-414. doi: 10.1373/clinchem.2016.261545. Epub 2016 Nov 10.

  PMID: 28062631 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

In accordance with the Third Universal Definition of MI and recommendations by both Canadian and international expert groups, we will collect and measure blood for cTnI and hs-cTn measurements at ED presentation and 3 hours later for patients who currently would only undergo a single cTn measurement and 6 hours later if serial cTn measurements are required. This does not preclude cTn measurements for clinical purposes at any additional times of choosing by the EP.

MeSH Terms

Conditions

Acute Coronary Syndrome; Emergencies; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Study Officials

• Andrew S Worster, MD, MSc, CCFP(EM), FCFP

  McMaster University

  PRINCIPAL INVESTIGATOR

• Kavsak Peter, PhD, FCACB, FACB

  McMaster University

  PRINCIPAL INVESTIGATOR

• Hill Stephen, PhD, FCACB

  McMaster University

  PRINCIPAL INVESTIGATOR

• McQueen J Mathew, MBChB, PhD, FCACB, FRCPC

  McMaster University

  PRINCIPAL INVESTIGATOR

• Devereaux P.J., MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Mehta Shamir, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

• Ma Jinhui, PhD

  Children's Hospital of Eastern Ontario Research Insititute

  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: November 19, 2013
• First Posted: November 26, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CA (1)