Recruiting

ECG Criteria

Sponsor:

Hennepin County Medical Center, Minneapolis

Code:

NCT02765477

Conditions

Acute Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT02765477

Start date

Jun, 2016

Status verified date

Nov, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

Apr, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1500 participants

Anticipated

Interventions and Outcome Measures

Arms

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%.

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 ]

Central Contacts and Locations

Central contacts

Stephen W Smith, M.D.

612-875-4226smith253@umn.edu

Locations

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

More Information

Sponsor

Hennepin County Medical Center, Minneapolis

Last update posted

Dec 1, 2016

Last verified

Nov, 2016

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hennepin County Medical Center, Minneapolis on 2016-12-01.