Acute Myocardial Infarction Clinical Trial
— PERFECTOfficial 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.
Status | Recruiting |
Enrollment | 1500 |
Est. completion date | July 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Case Control, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
United States | Hennepin County Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Hennepin County Medical Center, Minneapolis |
United States,
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. — View Citation
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. — View Citation
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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-cont — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Sensitivity and Specificity of the modified Sgarbossa criteria with criterion #2 extended from electrocardiogram leads V1-V3 to leads V1-V6 | 7 days | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | Performance characteristics of 0.5 mm (vs. 1 mm) concordant ST-deviation. | 7 days | No | |
Secondary | Performance characteristics of non-concave ST-morphology | 7 days | No | |
Secondary | Mean QRS amplitude of occlusion vs. no occlusion groups. Plot receiver-operator curve for QRS amplitude | 7 days | No | |
Secondary | Find mean T-wave amplitude in occlusion vs. no occlusion groups. Plot ROC curves for T/QRS ratio between groups. | 7 days | No | |
Secondary | Mean QTc, JTc, and TpTe in occlusion vs no occlusion groups, and plot ROC curves for QTc, JTc, and TpTe | 7 days | No | |
Secondary | 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. | 7 days | No |
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