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

This study is currently recruiting participants.
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Verified November 2016 by Stephen W. Smith, Hennepin County Medical Center, Minneapolis
Sponsor:
Information provided by (Responsible Party):
Stephen W. Smith, Hennepin County Medical Center, Minneapolis
ClinicalTrials.gov Identifier:
NCT02765477
First received: April 22, 2016
Last updated: November 29, 2016
Last verified: November 2016
April 22, 2016
November 29, 2016
June 2016
April 2017   (Final data collection date for primary outcome measure)
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 ]
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: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
Complete list of historical versions of study NCT02765477 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sensitivity and Specificity of the modified Sgarbossa criteria with criterion #2 extended from electrocardiogram leads V1-V3 to leads V1-V6 [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • Performance characteristics of other ECG millimeter cut-points for the third criterion of the modified Sgarbossa criteria (e.g. -0.2 and -0.3). [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • 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: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • Performance characteristics of 0.5 mm (vs. 1 mm) concordant ST-deviation. [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • Performance characteristics of non-concave ST-morphology [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • Differences in QRS amplitude between groups and performance characteristics of various cut-points. [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • Differences in T-wave amplitude and T/QRS ratio between groups and performance characteristics of various cutoffs. [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • Differences in repolarization measures in milliseconds, corrected for heart rate (e.g. QTc, JTc, TpTe) and performance characteristics of various cutoffs. [ Time Frame: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
  • 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: Acute cororonay occlusion as determined by the angiogram that is most temporally related to the electrocardiogram, during that patient's index hospitalization ]
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Paced Electrocardiogram Requiring Fast Emergent Coronary Therapy (PERFECT) Study
Paced Electrocardiogram Requiring Fast Emergent Coronary Therapy (PERFECT) Study
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.

BACKGROUND Diagnosis and management of ACO (the anatomic substrate for ST-elevation myocardial infarction) is time sensitive. Diagnosis necessitates emergent reperfusion therapy. An important predictor of death from ACO includes time to reperfusion.1 Delays in reperfusion therapy, including primary percutaneous coronary intervention (PCI) or fibrinolysis, are associated with worse 30-day and 1-year mortality. American Heart Association (AHA) guidelines for treatment of ACO recommend that the first medical contact to device time be less than 120 minutes in patients who have no contraindications to treatment.2 Though cardiac biomarkers are helpful in making the diagnosis in uncertain cases, the time sensitive nature of intervention for ACO precludes their use to direct emergent reperfusion therapy. Furthermore, biomarkers do not diagnose ACO but rather any AMI, including those without occlusion that do not need emergent intervention.

The "traditional" ECG diagnosis of ACO, which includes ST-elevation cutoffs based upon age and sex, excludes patients with ventricular paced rhythm (VPR).3 The small field of research on the topic of ACO in VPR has extrapolated and analyzed data from patients with left bundle branch block (LBBB). That is because VPR with right ventricular pacing and LBBB both result in depolarization from right to left through myocardium (not through conducting fibers) and thus result in similar ECG findings (e.g. wide QRS, delayed onset of depolarization, and abnormal repolarization with "discordant" [in the opposite direction of the QRS] T-waves and ST-segment deviation). In the presence of known LBBB, AHA guidelines recommend using the Sgarbossa criteria to make the diagnosis of ACO.4 Sgarbossa et al. proposed requiring at least 3 points from the following criteria for the diagnosis of acute myocardial infarction in the presence of LBBB: (1) concordant ST-segment elevation of 1 mm (0.1 mV) in at least 1 lead (5 points), (2) concordant ST-segment depression of at least 1 mm in leads V1 to V3 (3 points), or (3) excessively discordant ST-segment elevation, defined as greater than or equal to 5 mm of ST-segment elevation when the QRS complex is negative (2 points). There have been only a handful of evaluations of Sgarbossa's criteria in VPR, with variable methodologies and patient populations; sensitivities in the studies ranged from 10-53% and specificities ranged from 84-99%.5,6 Neither study used angiographic endpoints, but only used biomarker definitions of AMI; one study used a very flawed biomarker definition with no adjudication. Thus, the number of occlusions is entirely unknown and probably very small.

For LBBB, Smith et al. derived and validated a "modified Sgarbossa rule" in which they replaced Sgarbossa's third criterion (excessively discordant ST elevation as defined by 5 mm) with a proportion-based criterion (defined by > 25% of the previous S-wave) (see Table 1). This rule resulted in much higher sensitivity and accuracy for diagnosis of ACO than the original Sgarbossa.7,8

Table 1: MODIFIED SGARBOSSA CRITERIA

  1. ST-segment elevation >= 1 mm and concordant with the QRS in any lead
  2. ST-segment depression >= 1 mm and concordant with the QRS in any of leads V1- V3
  3. Proportionally excessive discordant ST-segment elevation in at least one lead, as defined by ST/S (</= -0.25) with at least 1 mm of STE

The modified Sgarbossa criteria have never been evaluated in patients with VPR and very few additional criteria have ever been evaluated. To our knowledge, no criteria have been evaluated using an angiographic outcome, the only outcome relevant to guiding emergency reperfusion therapy. The primary purpose of this study will be to investigate the diagnostic performance of selected ECG criteria for the diagnosis of ACO in VPR. Through the process of answering this question, a database will be formed to answer multiple additional questions on this patient population that is underrepresented in clinical trials.

STUDY DESIGN The primary analysis will be designed as a multicenter, retrospective case-control study. Additionally, data will be collected to create a database of de-identified patient information that will allow researchers to investigate numerous additional questions.

Study sites will include Hennepin County Medical Center (HCMC, the lead site) and academic and community centers (study sites) located internationally. Because AMI was redefined in 2007 by a rise and/or fall of troponin, with at least one value above the 99% reference value,9 our study will only include subjects that presented from January 1, 2008 through December 31, 2015.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
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Probability Sample

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.

Acute Myocardial Infarction
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  • 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%.


*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
July 2017
April 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
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
United States
 
 
NCT02765477
HSR 15-4101
No
Not Provided
Undecided
Not Provided
Stephen W. Smith, Hennepin County Medical Center, Minneapolis
Hennepin County Medical Center, Minneapolis
Not Provided
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
Hennepin County Medical Center, Minneapolis
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP