Acute Coronary SyndromeNCT02579512
Non Invasive Extra-corporeal ECG Signal Analysis Algorithm( NID Algorithm) for Myocardial Ischemia
An observational study of Acute Coronary Syndrome and Myocardial Ischemia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Acute Coronary Syndrome, Myocardial Ischemia
- What is being tested?
- Extra-corporeal ECG signal analysis
- How many people
- 500 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2015to May 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 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: myocardial Ischemia
Who may be able to join
- patient with acute coronary syndrome who accepted percutaneous coronary intervention
Who cannot join
- no percutaneous coronary intervention
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Yu-Tsung Cheng, M.D., 886423592525 ext. 3141, asphyxia747@hotmail.com
About this study
The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.
Read the detailed description
In this project, the investigators hope to compare the data collected under this new technology of NIA algorithm with results from final diagnoses of cardiac catheterization. As the NIA algorithm is a fast and less costly, if it provides more sensitivity and specificity than does exercise ECG, nuclear myocardial perfusion test, and high-resolution coronary CT angiogram, it will expedite diagnosis for patients with coronary artery disease.
- Conditions
- Acute Coronary Syndrome, Myocardial Ischemia
- Being tested
- Extra-corporeal ECG signal analysis
- Medical subject headings
- Acute Coronary Syndrome, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra-corporeal ECG signal analysisOther
The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.
| Study group | Role | What they receive |
|---|---|---|
| Extra-corporeal ECG Signal Analysis | Not described Receives: Other: Extra-corporeal ECG signal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiac Events (MACE)
MACE including de novo lesion , intra-stent stenosis, cardiac death and re-myocardial infarction
Measured: within the first 180 days after PCI (percutaneous coronary intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02579512
- Sponsor's protocol ID
- IGA1041203
- Status last verified
- Sep 2015
- First submitted
- 13 Jul 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
Publications
Lipton JA, Warren SG, Broce M, Abboud S, Beker A, Sornmo L, Lilly DR, Maynard C, Lucas BD Jr, Wagner GS. High-frequency QRS electrocardiogram analysis during exercise stress testing for detecting ischemia. Int J Cardiol. 2008 Feb 29;124(2):198-203. doi: 10.1016/j.ijcard.2007.02.002. Epub 2007 Apr 25.
PubMed 17462756Sharir T, Merzon K, Kruchin I, Bojko A, Toledo E, Asman A, Chouraqui P. Use of electrocardiographic depolarization abnormalities for detection of stress-induced ischemia as defined by myocardial perfusion imaging. Am J Cardiol. 2012 Mar 1;109(5):642-50. doi: 10.1016/j.amjcard.2011.10.022. Epub 2011 Dec 9.
PubMed 22169126Choi JO, Chang SA, Park SJ, Lee SC, Park SW. Improved detection of ischemic heart disease by combining high-frequency electrocardiogram analysis with exercise stress echocardiography. Korean Circ J. 2013 Oct;43(10):674-80. doi: 10.4070/kcj.2013.43.10.674. Epub 2013 Oct 30.
PubMed 24255651
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Extra-corporeal ECG Signal Analysis Algorithm( NID Algorithm) for Myocardial Ischemia
- ClinicalTrials.gov ID
- NCT02579512
- Acronym / sponsor ID
- IGA1041203
- Conditions
- Acute Coronary Syndrome, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 19 Oct 2015 (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 NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.
Detailed description
In this project, the investigators hope to compare the data collected under this new technology of NIA algorithm with results from final diagnoses of cardiac catheterization. As the NIA algorithm is a fast and less costly, if it provides more sensitivity and specificity than does exercise ECG, nuclear myocardial perfusion test, and high-resolution coronary CT angiogram, it will expedite diagnosis for patients with coronary artery disease.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Extra-corporeal ECG Signal Analysis | – | Other: Extra-corporeal ECG signal analysis |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- myocardial Ischemia
Key inclusion criteria (1 listed)
- patient with acute coronary syndrome who accepted percutaneous coronary intervention
Key exclusion criteria (1 listed)
- no percutaneous coronary intervention
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 |
|---|---|---|
| Extra-corporeal ECG signal analysisThe NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly. | Other | Extra-corporeal ECG Signal Analysis |
Primary outcome
Major Adverse Cardiac Events (MACE)
Time frame: within the first 180 days after PCI (percutaneous coronary intervention)
MACE including de novo lesion , intra-stent stenosis, cardiac death and re-myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Results publication: PubMed 17462756Lipton JA, Warren SG, Broce M, Abboud S, Beker A, Sornmo L, Lilly DR, Maynard C, Lucas BD Jr, Wagner GS. High-frequency QRS electrocardiogram analysis during exercise stress testing for detecting ischemia. Int J Cardiol. 2008 Feb 29;124(2):198-203. doi: 10.1016/j.ijcard.2007.02.002. Epub 2007 Apr 25.
- Results publication: PubMed 22169126Sharir T, Merzon K, Kruchin I, Bojko A, Toledo E, Asman A, Chouraqui P. Use of electrocardiographic depolarization abnormalities for detection of stress-induced ischemia as defined by myocardial perfusion imaging. Am J Cardiol. 2012 Mar 1;109(5):642-50. doi: 10.1016/j.amjcard.2011.10.022. Epub 2011 Dec 9.
- Results publication: PubMed 24255651Choi JO, Chang SA, Park SJ, Lee SC, Park SW. Improved detection of ischemic heart disease by combining high-frequency electrocardiogram analysis with exercise stress echocardiography. Korean Circ J. 2013 Oct;43(10):674-80. doi: 10.4070/kcj.2013.43.10.674. Epub 2013 Oct 30.
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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.
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 Acute Coronary Syndrome and Myocardial Ischemia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Oct 2015. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Tsung Cheng, M.D. (886423592525 ext. 3141, asphyxia747@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiac Events (MACE) (time frame: within the first 180 days after PCI (percutaneous coronary intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02579512, which also lists 3 linked publications.
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 19 Oct 2015.