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Paced Electrocardiogram Requiring Fast Emergent Coronary Therapy (PERFECT) Study (PERFECT)

This study is currently recruiting participants.
Verified November 2016 by Stephen W. Smith, Hennepin County Medical Center, Minneapolis
Sponsor:
ClinicalTrials.gov Identifier:
NCT02765477
First Posted: May 6, 2016
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephen W. Smith, Hennepin County Medical Center, Minneapolis
  Purpose
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.

Condition
Acute Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Paced Electrocardiogram Requiring Fast Emergent Coronary Therapy (PERFECT) Study

Resource links provided by NLM:


Further study details as provided by Stephen W. Smith, Hennepin County Medical Center, Minneapolis:

Primary Outcome Measures:
  • 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 [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • Sensitivity and Specificity of the modified Sgarbossa criteria with criterion #2 extended from electrocardiogram leads V1-V3 to leads V1-V6 [ Time Frame: 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 [ Time Frame: 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). [ Time Frame: 7 days ]
  • Performance characteristics of 0.5 mm (vs. 1 mm) concordant ST-deviation. [ Time Frame: 7 days ]
  • Performance characteristics of non-concave ST-morphology [ Time Frame: 7 days ]
  • Mean QRS amplitude of occlusion vs. no occlusion groups. Plot receiver-operator curve for QRS amplitude [ Time Frame: 7 days ]
  • Find mean T-wave amplitude in occlusion vs. no occlusion groups. Plot ROC curves for T/QRS ratio between groups. [ Time Frame: 7 days ]
  • Mean QTc, JTc, and TpTe in occlusion vs no occlusion groups, and plot ROC curves for QTc, JTc, and TpTe [ Time Frame: 7 days ]
  • Multivariate regression model including measurements of concordant and discordant ST elevation or depression, and of QRS amplitude, all in millimeters, and of repolarization time, in milliseconds. [ Time Frame: 7 days ]

Estimated Enrollment: 1500
Study Start Date: June 2016
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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%.


  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion from Primary Analysis:

    1. Extreme tachycardia (heart rate > 130 bpm) at the time of presentation
    2. Severe hypertension (diastolic blood pressure > 120 mmHg) at the time of presentation
    3. Respiratory failure (defined as need for positive pressure ventilation) due to pulmonary edema at the time of presentation.
    4. Hyperkalemia (serum potassium > 5.5 mEq/L) at the time of presentation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02765477


Contacts
Contact: Stephen W Smith, M.D. 612-875-4226 smith253@umn.edu
Contact: Deborah L Zvosec, Ph.D. 612-432-1677 Deborah.Zvosec@hcmed.org

Locations
United States, Minnesota
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Stephen W Smith, MD    612-875-4226    Stephen.Smith@hcmed.org   
Contact: Kenneth Dodd, MD    612-716-7085    Kenneth.Dodd@hcmed.org   
Sponsors and Collaborators
Hennepin County Medical Center, Minneapolis
Investigators
Study Chair: Kenneth W Dodd, M.D. Hennepin County Medical Center, Minneapolis, MN
Principal Investigator: Stephen W Smith, M.D. Hennepin County Medical Center, Minneapolis, MN
Study Director: Deborah L Zvosec, Ph.D. Minneapolis Medical Research Foundation
Study Chair: 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
  More Information

Publications:
American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions, 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, Anderson JL, Jacobs AK, Halperin JL, Albert NM, Brindis RG, Creager MA, DeMets D, Guyton RA, Hochman JS, Kovacs RJ, Kushner FG, Ohman EM, Stevenson WG, Yancy CW. 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):e78-140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17.
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, Menasché 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.

Responsible Party: Stephen W. Smith, Faculty Emergency Physician, Professor of Emergency Medicine, Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier: NCT02765477     History of Changes
Other Study ID Numbers: HSR 15-4101
First Submitted: April 22, 2016
First Posted: May 6, 2016
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Stephen W. Smith, Hennepin County Medical Center, Minneapolis:
Acute myocardial infarction
ST Elevation Myocardial Infarction
Acute Coronary Occlusion
Electrocardiogram
Ventricular Paced Rhythm
Modified Sgarbossa Criteria

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases