Acute Myocardial Infarction Clinical Trial
Official title:
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.
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Observational Model: Case Control, Time Perspective: Retrospective
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