Cardiac IschemiaMID-EPICNCT02055443
Myocardial Ischemia Detection for Early Identification of Patients With Ischemic Chest Pain
An observational study of Cardiac Ischemia and Chest Pain, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Ischemia, Chest Pain, Shortness of Breath
- What is being tested?
- 12-lead holter monitor application
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 18 years or older
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the detailed 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.
- Conditions
- Cardiac Ischemia, Chest Pain, Shortness of Breath
- Being tested
- 12-lead holter monitor application
- Keywords
- nuclear cardiology, chest pain, cardiac ischemia, shortness of breath, ECG, EKG, electrocardiogram
- Medical subject headings
- Coronary Artery Disease, Chest Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-lead holter monitor applicationOther
Also called H12+ holter ECG machine (Mortara Instruments, Milwaukee, WI)
-- 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.
| Study group | Role | What they receive |
|---|---|---|
| Holter monitor group | 12-lead holter monitor application Receives: Other: 12-lead holter monitor application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial ischemia
The primary outcome is the presence of radionuclide evidence of focal myocardial ischemia evidenced on nuclear cardiac stress testing (SPECT results).
Measured: 1-2 days per hospital SPECT protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salah Shafiq Al-Zaiti, University of Pittsburgh
- Investigators
- Salah Shafiq Al-Zaiti, PhD, Principal investigator, University of Pittsburgh School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055443
- Sponsor's protocol ID
- PRO13070234
- Acronym
- MID-EPIC
- Status last verified
- Jul 2017
- First submitted
- 30 Jan 2014
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ischemia Detection for Early Identification of Patients With Ischemic Chest Pain
- ClinicalTrials.gov ID
- NCT02055443
- Acronym / sponsor ID
- MID-EPIC / PRO13070234
- Conditions
- Cardiac Ischemia, Chest Pain, Shortness of Breath
- Keywords
- nuclear cardiology, chest pain, cardiac ischemia, shortness of breath, ECG, EKG, electrocardiogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 5 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Holter monitor group | – | Other: 12-lead holter monitor application12-lead holter monitor application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years or older
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-lead holter monitor applicationAlso: H12+ holter ECG machine (Mortara Instruments, Milwaukee, WI)-- 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. | Other | Holter monitor group |
Primary outcome
Myocardial ischemia
Time frame: 1-2 days per hospital SPECT protocol
The primary outcome is the presence of radionuclide evidence of focal myocardial ischemia evidenced on nuclear cardiac stress testing (SPECT results).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
Related trials for Cardiac Ischemia
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
RecruitingEarly Phase 1
Thiamine Intervention and Coronary Artery Bypass Grafting
Coronary Heart Disease, Coronary Artery Bypass Grafting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah Shafiq Al-Zaiti, PhD principal investigator
University of Pittsburgh School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Ischemia and Chest Pain, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial ischemia (time frame: 1-2 days per hospital SPECT protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.