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Are Serial Electrocardiograms Additive to SeriAl Second-generations Troponins in Predicting Acute CoronAry Syndromes in PatienTs With Undifferentiated cHest Pain (ASAP Cath)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Wake Forest Baptist Health
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Roberty Riley, Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01953276
First received: September 25, 2013
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

Our research will examine whether the presence or absence of serial electrocardiogram (ECG) changes aids in reclassifying participants' risk for major adverse cardiac events (MACE) over and above serial blood testing.


Condition Intervention
Acute Coronary Syndrome
Chest Pain
Device: Serial Electrocardiograms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Are Serial Electrocardiograms Additive to SeriAl Second-generations Troponins in Predicting Acute CoronAry Syndromes in PatienTs With Undifferentiated cHest Pain (ASAP CATH) Study

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Major Adverse Cardiovascular Events at 30 days [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Determine whether serial electrocardiogram changes significantly increase the diagnostic accuracy of serial second-generation troponin measurements in predicting MACE at 30 days in patients with symptoms suggestive of ACS.

  • Evidence of acute myocardial ischemia via objective cardiac testing performed during the index hospitalization [ Time Frame: Duration of initial hospitalization, usually 1 to 2 days ] [ Designated as safety issue: No ]
    Determine whether serial ECG changes significantly increase the diagnostic accuracy of serial second-generation troponin measurements in predicting positive cardiac stress testing or coronary angiography findings indicative of acute myocardial ischemia in patients being evaluated for ACS.

  • Major Adverse Cardiovascular Events at 30 days [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]
    Determine whether serial ECG changes significantly increase the diagnostic accuracy of serial second-generation troponin measurements in predicting major adverse cardiovascular events at 30 days in patients with symptoms suggestive of ACS.


Biospecimen Retention:   Samples With DNA

Whole blood samples are obtained from patients and processed so that the plasma is extracted and frozen for future research.


Estimated Enrollment: 382
Study Start Date: January 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Serial Electrocardiogram Arm
All study participants will receive serial electrocardiograms.
Device: Serial Electrocardiograms
All participants will have serial electrocardiograms performed.

Detailed Description:

Chest pain is one of the most common symptoms evaluated in the Emergency Department (ED). One of the primary diagnostic concerns during the evaluation of this presentation is whether there is evidence of acute coronary syndromes (ACS) as ACS is a major risk factor for short- and long-term major adverse cardiovascular events (MACE, defined as acute myocardial infarction, revascularization, or all-cause death). Two of the cornerstones of the guidelines-based evaluation of this patient group are serial electrocardiograms (ECG) and troponin measurements (a serological marker of myocardial ischemia), which have shown to be both independently and incrementally predictive of ACS. Recently, second-generation troponin assays have been adopted into clinical practice as they have higher sensitivity and specificity for ACS compared to older assays. Given the increased diagnostic accuracy of these novel second-generation assays, the proposed study's research question is to investigate whether serial ECG changes significantly increase the diagnostic accuracy of serial second-generation troponin changes in predicting MACE in patients presenting with symptoms consistent with ACS. In order to investigate this question, we originally proposed an observational pilot study ancillary to the HEART Pathway trial (WFUHS IRB00021074), a funded randomized controlled trial investigating a recently developed decision aid tool (the HEART score) designed to identify patients being evaluated for chest pain that can safely forgo further objective testing. We proposed to add the collection of two additional 12-lead ECGs to the protocol in the HEART Pathway trial, which included serial second-generation troponin collection, in order to generate pilot data regarding the research question. As recruitment for the HEART Pathway trial ended in February 2014, we now propose to continue enrollment for the ASAP CATH study independently, as a prospective observational study evaluating the additional prognostic value of serial ECGs to standard care in patients with chest pain being evaluated for acute coronary syndromes in the Emergency Department.

Objective:

The goal of this project is to produce preliminary data to investigate whether the presence or absence of serial ECG changes suggestive of myocardial ischemia aids in reclassifying participants' risk for MACE and objective evidence of ACS over and above serial second-generation troponin testing.

Methods:

Adult patients, over 21 years old, presenting to WFBMC ED with chest pain or symptoms concerning for ACS, in which the provider orders cardiac biomarkers and an ECG will be eligible for enrollment. We aim to add serial ECG analysis (one at the time of study enrollment and a second at the time of the study blood draw) to the protocol in the proposed study. The primary outcomes are major adverse cardiovascular events (MACE) at 30 days and evidence of acute myocardial ischemia via objective cardiac testing performed during the index hospitalization.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to the Wake Forest Baptist Health Emergency Department with symptoms concerning for Acute Coronary Syndrome (ACS) are eligible for enrollment.

Criteria

Inclusion Criteria:

  • Age greater than or equal to 21 years of age at the time of enrollment
  • Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
  • The treating physician feels the patient could be discharged home if cardiac disease was excluded

Exclusion Criteria:

  • Evidence of ST-elevation myocardial infarction (STEMI) or left bundle branch block (LBBB) on initial ECG
  • Left ventricular systolic dysfunction (history of left ventricular ejection fraction <40% or active symptoms of congestive heart failure)
  • New or uncontrolled ventricular arrhythmias on initial ECG
  • Hemodynamic instability: heart rate > 120 bpm or < 40 bpm and/or systolic blood pressure <100 mmHg
  • Hypoxemia (oxygen saturation <90% on room air or normal home oxygen flow rate)
  • Terminal diagnosis with life expectancy less than 1 year
  • A non-cardiac medical, surgical, or psychiatric illness determined by the provider to require admission, increase risk of objective cardiac testing, or prevent immediate discharge following negative testing.
  • Prior enrollment
  • Incapacity or unwillingness to provide consent and comply with study procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953276

Contacts
Contact: Stephanie Bradshaw Elliott, B.S. (336) 716-5943 sbradsha@wakehealth.edu
Contact: Erin Harper, M.S.H.S. (336) 716-2059 erharper@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center - Emergency Department Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Stephanie Bradshaw Elliott, B.S.    336-716-5943    sbradsha@wakehealth.edu   
Contact: Erin Harper, M.S.H.S.    (336) 716-2059    erharper@wakehealth.edu   
Principal Investigator: Robert F Riley, MD         
Sponsors and Collaborators
Wake Forest Baptist Health
American Heart Association
Investigators
Principal Investigator: Robert F Riley, MD Wake Forest Baptist Health
  More Information

Publications:
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. No abstract available. Erratum in: Circulation. 2008 Mar 4;117(9):e180.
Luepker RV, Apple FS, Christenson RH, Crow RS, Fortmann SP, Goff D, Goldberg RJ, Hand MM, Jaffe AS, Julian DG, Levy D, Manolio T, Mendis S, Mensah G, Pajak A, Prineas RJ, Reddy KS, Roger VL, Rosamond WD, Shahar E, Sharrett AR, Sorlie P, Tunstall-Pedoe H; AHA Council on Epidemiology and Prevention; AHA Statistics Committee; World Heart Federation Council on Epidemiology and Prevention; European Society of Cardiology Working Group on Epidemiology and Prevention; Centers for Disease Control and Prevention; National Heart, Lung, and Blood Institute. Case definitions for acute coronary heart disease in epidemiology and clinical research studies: a statement from the AHA Council on Epidemiology and Prevention; AHA Statistics Committee; World Heart Federation Council on Epidemiology and Prevention; the European Society of Cardiology Working Group on Epidemiology and Prevention; Centers for Disease Control and Prevention; and the National Heart, Lung, and Blood Institute. Circulation. 2003 Nov 18;108(20):2543-9. Epub 2003 Nov 10.
Thygesen K, Alpert JS, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, Jaffe AS, Apple FS, Galvani M, Katus HA, Newby LK, Ravkilde J, Chaitman B, Clemmensen PM, Dellborg M, Hod H, Porela P, Underwood R, Bax JJ, Beller GA, Bonow R, Van der Wall EE, Bassand JP, Wijns W, Ferguson TB, Steg PG, Uretsky BF, Williams DO, Armstrong PW, Antman EM, Fox KA, Hamm CW, Ohman EM, Simoons ML, Poole-Wilson PA, Gurfinkel EP, Lopez-Sendon JL, Pais P, Mendis S, Zhu JR, Wallentin LC, Fernández-Avilés F, Fox KM, Parkhomenko AN, Priori SG, Tendera M, Voipio-Pulkki LM, Vahanian A, Camm AJ, De Caterina R, Dean V, Dickstein K, Filippatos G, Funck-Brentano C, Hellemans I, Kristensen SD, McGregor K, Sechtem U, Silber S, Tendera M, Widimsky P, Zamorano JL, Morais J, Brener S, Harrington R, Morrow D, Lim M, Martinez-Rios MA, Steinhubl S, Levine GN, Gibler WB, Goff D, Tubaro M, Dudek D, Al-Attar N. Universal definition of myocardial infarction. Circulation. 2007 Nov 27;116(22):2634-53. Epub 2007 Oct 19.
Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. Review. No abstract available.

Responsible Party: Roberty Riley, Principal Investigator, Wake Forest Baptist Health
ClinicalTrials.gov Identifier: NCT01953276     History of Changes
Other Study ID Numbers: IRB00022288
Study First Received: September 25, 2013
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
Acute Coronary Syndrome
Chest pain
Electrocardiograms
Risk Stratification
Emergency Department

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014