Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02055443
Other study ID # PRO13070234
Secondary ID
Status Completed
Phase N/A
First received January 30, 2014
Last updated July 10, 2017
Start date January 2014
Est. completion date December 2016

Study information

Verified date July 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate whether new novel markers from the clinical electrocardiogram (EKG), which have been used as non-invasive measures of heart disease, can detect coronary artery disease in patients with chest pain. The researchers are especially interested in studying how changes in these unique waves evolve over time with rest and activity. It is hoped that the findings will be helpful in differentiating patients with cardiac chest pain at emergency departments from those with non-cardiac chest pain, as early identification can accelerate treatment and save lives.

Eligible participants are those age 18 and older who have been referred for a nuclear stress test at University of Pittsburgh Medical Center Presbyterian Hospital to rule out coronary artery disease as part of their clinical care.


Description:

Acute Coronary Syndrome (ACS) is the leading cause of death worldwide. Differentiating ACS from other non-ischemic chest pain is imperative in emergency medicine and missed myocardial infarction remains one of the highest sources of medical malpractice in Emergency Departments (ED). At the same time, economic pressures and limited resources demand that physicians avoid hospital admission or protracted observation for every patient with chest pain or suspicious symptoms. In the absence of clear ST elevation (STE) on the electrocardiogram (ECG), ED providers have no reliable tools to quickly triage non-STE (NSTE) ACS patients. Current guidelines rely on blood biomarkers (e.g. cardiac enzymes) to identify this syndrome and do not completely describe ischemic ECG changes associated with it. ED Providers will need to delay the management of these high risk patients until cardiac biomarkers are withdrawn, analyzed, and interpreted. This results in greater mortality rates in NSTE-ACS patients and overburdens the healthcare system. The prolonged observation times at EDs and unnecessary admissions are just additional consequences that overuse nursing times and exacerbate nursing shortage.

ECG changes other than ST elevation and dynamic ECG changes are a rich opportunity for improving diagnostics. This proposal intends to provide new insights into how ischemic repolarization changes evolve over time in the subacute phase of myocardial ischemia. Sixty patients with suspected coronary artery disease referred for nuclear cardiac stress testing will be included. Resting 12-lead ECGs will be obtained before the stress test and one after the stress test but before the nuclear scan. Alterations in novel, computerized T wave indices will be correlated with focal myocardial ischemia seen on nuclear scans. Repeated Measures ANOVA with between group comparisons, and Generalized Estimation Equation will be used in the analysis. The results will provide insight on the diagnostic value of different novel T wave indices to detect myocardial ischemia. Results from this study will provide tools for ED providers to distinguish ACS from non-ischemic chest pain patients early in the triage process, especially in the absence of STE that constitutes the common standard nowadays.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults > 18 years of age

- referred for nuclear cardiac stress testing for suspected coronary artery disease.

There will be no restrictions to sex or race. Children and teens are less likely to have ischemic etiology of chest pain, justifying their exclusion. To optimize the clinical utility, there will be no exclusion criteria based on previous medical history, medications, or presenting chief complaint; all consecutive patients will be eligible.

Exclusion Criteria:

- Patients with un-interpretable ECGs or their ECG shows known secondary repolarization abnormalities (i.e. bundle branch blocks, ventricular hypertrophy, channelopathies, early repolarization) will be excluded. Of note, as per clinical guidelines, these patients do not get usually referred for exercise treadmill testing. This will improve the recruitment process of this study.

Study Design


Intervention

Other:
12-lead holter monitor application
-- The study coordinator will then obtain a 5-minute baseline high resolution (1000 samples/second), 12-lead resting ECG stream using H12+ holter ECG machine (Mortara Instruments, Milwaukee, WI). This ECG will be performed before the subject completed their clinical stress test. The patient will then complete the scheduled nuclear stress test that involves exercise treadmill testing followed by single-photon emission computerized tomography (SPECT) scan as per hospital protocols. The exercise treadmill test and SPECT nuclear imaging scan are clinical in nature, and therefore, separate from the research study. After completing the scheduled exam, the study coordinator will obtain another 5-minute 12-lead ECG stream prior to removing the chest electrodes but before their nuclear scan.

Locations

Country Name City State
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Myocardial ischemia The primary outcome is the presence of radionuclide evidence of focal myocardial ischemia evidenced on nuclear cardiac stress testing (SPECT results). 1-2 days per hospital SPECT protocol
See also
  Status Clinical Trial Phase
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Recruiting NCT03664973 - Serratus Plane Block for Rib Fractures N/A
Completed NCT02905383 - The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital N/A
Not yet recruiting NCT05649891 - Checklists Resuscitation Emergency Department N/A
Withdrawn NCT03906812 - A Randomized Trial of Telemetry Compared With Unmonitored Floor Admissions in ED Patients With Low-Risk Chest Pain N/A
Active, not recruiting NCT02892903 - In the Management of Coronary Artery Disease, Does Routine Pressure Wire Assessment at the Time of Coronary Angiography Affect Management Strategy, Hospital Costs and Outcomes? N/A
Completed NCT02538861 - Acute Chest Pain Imaging in the ED With the Combine CCTA and CT Perfusion
Completed NCT02538770 - Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization N/A
Completed NCT01931852 - Cardiac Magnetic Resonance Imaging Strategy for the Management of Patients With Acute Chest Pain and Detectable to Elevated Troponin N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Completed NCT01665521 - Efficacy Evaluation of the HEART Pathway in Emergency Department Patients With Acute Chest Pain N/A
Recruiting NCT01542086 - Comparison of the Cost-Effectiveness of Coronary CT Angiography Versus Myocardial SPECT in Patients With Intermediate Risk of Coronary Heart Disease N/A
Completed NCT01486030 - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test
Completed NCT01604655 - ProspEctive First Evaluation in Chest Pain Trial N/A
Terminated NCT01836211 - High-Sensitivity Troponin T and Coronary Computed Tomography Angiography for Rapid Diagnosis of Emergency Chest Pain N/A
Completed NCT01163019 - 2D Strain Echocardiography for Diagnosing Chest Pain in the Emergency Room N/A
Completed NCT00709670 - ComParative Diagnostic Study Between Multislice Computed Tomography (MSCT) and Stress Echography in Coronarin Patients. N/A
Completed NCT00536224 - Chest Pain Observation Unit Risk Reduction Trial N/A
Terminated NCT00221182 - Stem Cell Study for Patients With Heart Disease Phase 1/Phase 2
Completed NCT00075088 - Tele-Electrocardiography in Emergency Cardiac Care Phase 3