Paced Electrocardiogram Requiring Fast Emergent Coronary Therapy (PERFECT) Study

NCT02765477 | Unknown

• 1 other identifier: HSR 15-4101
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The number of patients with cardiovascular implantable electronic devices (CIED), including ventricular pacemakers, continues to increase. However, there are no accurate electrocardiographic (ECG) criteria to diagnose acute myocardial infarction (AMI), even if due to acute coronary occlusion (ACO), with a ventricular pacemaker in situ. In this retrospective, multicenter, case-control study the investigators will examine ECG criteria to diagnose ACO in patients with ventricular paced rhythms. During this process, the investigators will also create a database from which investigators will be able to answer multiple additional questions on this population of patients.

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction; ST Elevation Myocardial Infarction; Acute Coronary Occlusion; Electrocardiogram; Ventricular Paced Rhythm; Modified Sgarbossa Criteria

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specificity of Modified Sgarbossa Criteria for Diagnosis of Acute Coronary Occlusion in the Setting of Ventricular Paced Rhythm in Patients with Potential Ischemic Symptoms

  7 days

Secondary Outcomes (9)

• Sensitivity and Specificity of the modified Sgarbossa criteria with criterion #2 extended from electrocardiogram leads V1-V3 to leads V1-V6

  7 days

• Performance characteristics of the modified Sgarbossa criteria using a maximum ST/S ratio of -0.20, and of -0.30, instead of -0.25

  7 days

• Performance characteristics of absolute ECG millimeter measurements of ST discordance (including both discordant ST elevation and ST depression), using various ratio cutoffs (e.g. -0.2, -0.25, -0.3).

  7 days

• Performance characteristics of 0.5 mm (vs. 1 mm) concordant ST-deviation.

  7 days

• Performance characteristics of non-concave ST-morphology

  7 days

Study Arms (4)

Angiogram Cohort w Acute Coronary Occlusion

Inclusion Criteria: Angiogram Cohort. Patients who present 1) directly through the study site Emergency Department (ED) OR 2) as a transfer or referral patient from the ED of another institution OR 3) as a direct admission to the study site's Catheterization Laboratory by an ambulance service, who also met the following criteria: 1.Underwent urgent or emergent coronary angiography during the index presentation for suspected ischemic symptoms (including but not limited to chest pain \[CP\] and/or shortness of breath \[SOB\]) AND 2. Had a VPR ECG recorded during the index presentation prior to the angiogram AND 3. Had sufficient troponins to rule in or rule out acute myocardial injury, per the study site's institutional protocol. From this Angiogram Cohort, a group of patients will be identified who had angiographic evidence of ACO, defined as an acute lesion with TIMI flow 0 or 1 when evaluated by an experienced study-site adjudicator.

Non-ACO Angiogram Cohort

Inclusion Criteria: Angiogram Cohort. Each study site will first identify adult patients (age 18 years or older) who presented to the study site 1) directly through the study site ED OR 2) as a transfer or referral patient from the ED of another institution OR 3) as a direct admission to the study site's Catheterization Laboratory by an ambulance service, who also met the following criteria: 1. Underwent coronary angiography during the index presentation for suspected ischemic symptoms (including but not limited to CP and/or SOB AND 2. Had a VPR ECG recorded during the index presentation prior to the angiogram AND 3. Had sufficient troponins to rule in or rule out acute myocardial injury, per the study site's institutional protocol. From this Angiogram Cohort, those who had TIMI-2 or greater flow will be identified for several research questions.

Random ED Sample w Paced Rhythm but No AMI

Each site will select a random sample of all adult patients who present to the ED (or by ambulance directly to the Catheterization Lab) with suspected ischemic symptoms and a VPR ECG. Each study site will randomly select 5 unique encounters for every one 1 ACO subject identified by the site. If a study site identifies no ACO subjects, they will randomly select 30 unique encounters. Study subjects who are included as subjects in the Angiogram Cohort (data set #1, above) and who are also selected as part of the random sample (data set #2) will be identified in REDCap as subjects for analysis in both groups, but their data will be submitted only once. The primary control group selected from this search will be all patients in this group who do not meet criteria for acute myocardial injury, as defined by 1) all troponins below the 99th percentile or 2) Peak troponin \< 3x the upper limit of normal AND no rise and/or fall of \> 30%.

ED Patients w Paced Rhythm Without AMI excluded

Each site will select a random sample of all adult patients who present to the ED (or by ambulance directly to the Catheterization Lab) with suspected ischemic symptoms and a VPR ECG. Each study site will randomly 5 unique encounters for every 1 ACO subject identified by the site. If a study site identifies no ACO subjects, they will randomly select 30 unique encounters. Study subjects who are included as subjects in the Angiogram Cohort (data set #1, above) and who are also selected as part of the random sample (data set #2) will be identified in REDCap as subjects for analysis in both groups, but their data will be submitted only once. The secondary control group will include patients in this group in whom Acute MI cannot be excluded because they either have at least 1 troponin \> 3x the upper limit of normal or they have at least 1 troponin between 1x and 3x the ULN AND have a rise and/or fall of at least 30%.

Eligibility Criteria

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

Study Population

I. Adults who presented either 1) directly through the Emergency Department (ED), 2) as a transfer or referral patient, or 3) as a direct ambulance admission to the Catheterization Laboratory, who also: 1. Underwent urgent or emergent coronary angiography during the index presentation for suspected ischemic symptoms, and 2. Had a ventricular paced rhythm (VPR) on the ECG 3. Had sufficient troponins to rule in or rule out acute myocardial injury, per the study site's institutional protocol. II. Next, each study site will identify all adult ED patients with a VPR ECG recorded during the index presentation who presented with suspected ischemic symptoms. Simple random selection will be used to identify subjects from this population. There may be overlap between this group and the angiogram group above and this will be considered at the data analysis stage (see Procedures Manual for more detail). The first group will not be a probability sample, but the second group will be.

You may qualify if:

• year old at least, ischemic symptoms (e.g., chest pain, shortness of breath, etc.), ventricular paced rhythm on the Electrocardiogram (ECG).

You may not qualify if:

• Extreme tachycardia (heart rate \> 130 bpm) at the time of presentation
• Severe hypertension (diastolic blood pressure \> 120 mmHg) at the time of presentation
• Respiratory failure (defined as need for positive pressure ventilation) due to pulmonary edema at the time of presentation.
• Hyperkalemia (serum potassium \> 5.5 mEq/L) at the time of presentation.

Sponsors & Collaborators

• Hennepin County Medical Center, Minneapolis: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

RECRUITING

Related Publications (9)

• O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.

  PMID: 23256914 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.

  PMID: 22922414 BACKGROUND

• Sgarbossa EB. Recent advances in the electrocardiographic diagnosis of myocardial infarction: left bundle branch block and pacing. Pacing Clin Electrophysiol. 1996 Sep;19(9):1370-9. doi: 10.1111/j.1540-8159.1996.tb04217.x. No abstract available.

  PMID: 8880802 BACKGROUND

• Jaffe AS. Third universal definition of myocardial infarction. Clin Biochem. 2013 Jan;46(1-2):1-4. doi: 10.1016/j.clinbiochem.2012.10.036. Epub 2012 Nov 2. No abstract available.

  PMID: 23127386 BACKGROUND

• Nielsen PH, Terkelsen CJ, Nielsen TT, Thuesen L, Krusell LR, Thayssen P, Kelbaek H, Abildgaard U, Villadsen AB, Andersen HR, Maeng M; Danami-2 Investigators. System delay and timing of intervention in acute myocardial infarction (from the Danish Acute Myocardial Infarction-2 [DANAMI-2] trial). Am J Cardiol. 2011 Sep 15;108(6):776-81. doi: 10.1016/j.amjcard.2011.05.007. Epub 2011 Jul 15.

  PMID: 21757183 RESULT

• Sgarbossa EB, Pinski SL, Barbagelata A, Underwood DA, Gates KB, Topol EJ, Califf RM, Wagner GS. Electrocardiographic diagnosis of evolving acute myocardial infarction in the presence of left bundle-branch block. GUSTO-1 (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries) Investigators. N Engl J Med. 1996 Feb 22;334(8):481-7. doi: 10.1056/NEJM199602223340801.

  PMID: 8559200 RESULT

• Maloy KR, Bhat R, Davis J, Reed K, Morrissey R. Sgarbossa Criteria are Highly Specific for Acute Myocardial Infarction with Pacemakers. West J Emerg Med. 2010 Sep;11(4):354-7.

  PMID: 21079708 RESULT

• Meyers HP, Limkakeng AT Jr, Jaffa EJ, Patel A, Theiling BJ, Rezaie SR, Stewart T, Zhuang C, Pera VK, Smith SW. Validation of the modified Sgarbossa criteria for acute coronary occlusion in the setting of left bundle branch block: A retrospective case-control study. Am Heart J. 2015 Dec;170(6):1255-64. doi: 10.1016/j.ahj.2015.09.005. Epub 2015 Sep 24.

  PMID: 26678648 RESULT

• Smith SW, Dodd KW, Henry TD, Dvorak DM, Pearce LA. Diagnosis of ST-elevation myocardial infarction in the presence of left bundle branch block with the ST-elevation to S-wave ratio in a modified Sgarbossa rule. Ann Emerg Med. 2012 Dec;60(6):766-76. doi: 10.1016/j.annemergmed.2012.07.119. Epub 2012 Aug 31.

  PMID: 22939607 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Kenneth W Dodd, M.D.

  Hennepin County Medical Center, Minneapolis, MN

  STUDY CHAIR

• Stephen W Smith, M.D.

  Hennepin County Medical Center, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

• Deborah L Zvosec, Ph.D.

  Hennepin Healthcare Research Institute

  STUDY DIRECTOR

• Rehan Karim, MBBS

  Hennepin County Medical Center, Minneapolis, MN

  STUDY CHAIR

• Louise Cullen, MD

  Royal Brisbane and Women's Hospital

  STUDY CHAIR

• Richard Body, MD, PhD

  The University of Manchester

  STUDY CHAIR

Central Study Contacts

Stephen W Smith, M.D.

CONTACT

612-875-4226; smith253@umn.edu

Deborah L Zvosec, Ph.D.

CONTACT

612-432-1677; Deborah.Zvosec@hcmed.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Emergency Physician, Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: December 1, 2016

Record last verified: 2016-11

Locations

US (1)