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Acute Myocardial Infarction, of Inferolateral WallNCT03387280

ECG Identifying the Culprit Coronary Artery

An observational study of Acute Myocardial Infarction, of Inferolateral Wall and Acute Myocardial Infarction, of Inferoposterior Wall, run by Yuan's General Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Acute myocardial infarction (AMI) usually occurs suddenly and is associated with considerably high mortality rate. The infarct-related artery in inferior wall AMI is usually located at right coronary artery (RCA), less often at left circumflex coronary artery (LCX). Read more about this study

Who is it for?
Ages 40 to 85 years
How many people
150 participants
Where
1 siteTaiwan
Study dates
Jan 2015to May 2018
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: From review of the medical records, patients suffered from first inferior wall AMI will be enrolled in this study. The diagnosis of acute inferior AMI includes: 1) chest pain > 30 minutes; 2) ST elevation > 1mm in at least two of the three inferior lead (II, III, AVF); and 3) 2-fold increase in serum creatine kinase levels. At least 2 of the above 3 criteria are necessary to confirm the diagnosis.

Who may be able to join

  • first attacked acute inferior MI patients

Who cannot join

  • those with 1). previous AMI, 2). coronary artery bypass surgery, 3). electrocardiographic evidence of bundle branch block, 4). undetermined culprit site by coronary angiography, 5) first electrocardiogram obtained more than 12 hours after the onset of symptoms.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Yuan's General Hospital

    Kaohsiung City, 802

    Shoa-Lin Lin, M.D., 886-73351121 ext. 1771, sllin@yuanhosp.com.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Electrocardigram Identifying the Culprit Site in Patients With Acute Inferior Myocardial Infarction

Acute myocardial infarction (AMI) usually occurs suddenly and is associated with considerably high mortality rate. The infarct-related artery in inferior wall AMI is usually located at right coronary artery (RCA), less often at left circumflex coronary artery (LCX). Inferior wall AMI occlusive site before the first right ventricular branch of RCA was more frequently associated with right ventricular infarction, which had higher incidence of bradyarrhythmia, shock, and in-hospital death. Early recognition of the site of infarct-related artery especially combination with right ventricular infarction and respond promptly may result in a significant reduction in in-hospital mortality and morbidity. There were several non-invasive methods to predict the culprit site, which including: radioneuclear imaging study, echocardiography or electrocardiogram. Among these methods, electrocardiogram is one of the most simple and convenient tool. Several algorisms have investigated but these algorisms included using leads III, II, I, aVL, V1, V2, V3, V5 and V6, which can only differentiate RCA and LCX lesions but cannot assure whether the culprit site is located at proximal or distal RCA. Thus, the aim of this study is designing a method which is simple and useful in identifying the culprit sites in inferior wall acute myocardial infarction (AMI).

According to the medical record, patients with inferior wall AMI who have no previous history of MI (or the first AMI attack) will be enrolled. These patients are divided into 3 groups from coronary angiography, depending upon the culprit lesion (1) before (proximal) or (2) after (distal) the right ventricular branch of RCA and (3) LCX. A two-step study strategy will be performed to analyze which electrocardiographic variables are capable of discriminating the culprit site of coronary artery. Using the area under the receiver operating characteristic (ROC) curve analysis, we plan to determine which one of the above variables is the most powerful criterion in discriminating the culprit site of coronary artery. Due to the fact that the case number of the first inferior AMI will be limited, this study will be carried out at 3 hospitals in order to collect more cases with the coming year.

Read the detailed description

Background

Acute myocardial infarction (AMI) usually occurs suddenly and is associated with considerably high mortality rate. The infarct-related artery in inferior wall AMI is usually located at right coronary artery (RCA), less often at left circumflex coronary artery (LCX). [1,2] Inferior wall AMI occlusive site above the first right ventricular branch of RCA was more frequently associated with right ventricular infarction, which had higher incidence of bradyarrhythmia, shock, and in-hospital death.[3-7] Early recognition of the site of infarct-related artery and respond promptly may result in a significant reduction in in-hospital mortality and morbidity.[8-10] Coronary angiography is considered to be the gold standard for determining the culprit site of infarct-related artery, but it is an invasive examination. Additionally, not all hospitals have the facility in performing the cardiac catheterization. There were several non-invasive methods to predict the culprit site including: radioneuclear imaging study, echocardiography or electrocardiogram. Among these methods, electrocardiogram is one of the most simple and useful tools. Several studies have used ST segment elevation in lead III > ST segment elevation in lead II and ST segment depression in lead I, aVL or both to predict that culprit site was located at RCA; ST segment elevation in lead I, aVL, V5 and V6 and ST segment depression in V1, V2 and V3 to predict that the culprit site was located at LCX. [11-24] These electrocardiogram readings including lead III, II, I, aVL, V1, V2, V3, V5 and V6 , which can only differentiate RCA and LCX lesions. If clinicians are intended to know whether the culprit site is located at proximal or distal RCA, further evaluation of the ST segment elevation in leads V1 and V4R,would be needed [25] which makes the algorithm involving too many leads and not so easy to remember. Thus, the aim of this study is designing a method which is simple and useful in identifying the culprit sites in inferior wall acute myocardial infarction (AMI).

Methods

Study Patients:

From review of the medical records, patients suffered from first inferior wall AMI will be enrolled in this study. The diagnosis of acute inferior AMI includes: 1) chest pain > 30 minutes; 2) ST elevation > 1mm in at least two of the three inferior lead (II, III, AVF); and 3) 2-fold increase in serum creatine kinase levels. At least 2 of the above 3 criteria are necessary to confirm the diagnosis. Right ventricular infarction is diagnosed by the presence of an ST-segment elevation of 0.1 mV in the V3R or V4R lead (recorded in all patients with inferior wall MI) in the electrocardiogram performed within 15 minutes after arrival at emergent department. Exclusion criteria include previous AMI or coronary artery bypass surgery, electrocardiographic evidence of bundle branch block, undetermined culprit site by coronary angiography, or first electrocardiogram obtained more than 12 hours after the onset of symptoms. Patient's demographic variables, important risk factors and clinical outcomes including atrioventricular block, arrhythmia, shock, mortality during the first hospital days are recorded.

All patients received dual anti-platelates with aspirin and clopidegrol, and anti-coagulant (low molecular weight heparin or unfractured heparin) regimen. Most of the patients have received primary percutanuous coronary intervention. The GpIIb/IIIa antagonists is administered in all patients.

Electrocardiogarphy:

Standard 12-lead electrocardiogram is performed within 12 hours after onset of chest pain in all study patients. ST-segment deviation from isoelectric line will be measured with a calliper at the point of 80 ms after the J point. The preceding TP-segment is considered as the isoelectric line. The magnitudes of ST-segment deviation in 12-lead electrocardiogram and V4R are also assessed.

Coronary angiography:

Coronary angiography is performed during the first day of admission. The cineangiography films are reviewed by 2 interventional cardiologists who are blinded to the electrocardiographic findings. The culprit artery is defined as total occlusion (Thrombolysis in Myocardial Infarction, TIMI grade 0) or significant stenosis (> 70% diameter stenosis) of RCA or LCX and of their major branches with intraluminal thrombosis or supply to hypokinetic territory. The occlusion site of infarct-related coronary artery determined by coronary angiography is classified into three groups: proximal RCA: lesion proximal to the first right ventricular branch of the RCA; distal RCA: lesion distal to the first right ventricular branch of the RCA; and LCX groups.

Statistical analysis:

The data of electrocardiographic findings, patient's characteristics and clinical outcomes are presented as mean ± standard deviation for continuous variables and frequency distribution for discrete variables. Chi-square analysis is used to assess the association of patients' characteristics with site of culprit lesion. One way ANOVA with Bonferroni post hoc test are used to assess the relation between site of culprit lesion and electrocardiographic findings. The value of P ≤ 0.05 is considered statistically significant. The cut-off point of electrocardiographic criteria for predicting culprit coronary artery is determined by receiver operating characteristic (ROC) curve. The area under the ROC curve represents the diagnostic validity of each cut-off points will be determined and compared.

Keywords
acute myocardial infarction, electrocardiogram, coronary angiography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03387280
Study groupRoleWhat they receive
proximal RCA stenosisThe stenosis site is before the the right ventricular branch of right coronary artery (RCA) according to the coronary angiograms.
distal RCA stenosisThe stenosis site is after the the right ventricular branch of right coronary artery (RCA) according to the coronary angiograms.
left circumflex coronary artery stenosisThe stenosis site is located at the left circumflex coronary artery according to the coronary angiograms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. determine which criteria is the best one in predicting the culprit site

    using ROC curve analysis in the final comparison

    Measured: about 1-2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2018
  2. Study startJan 2015
  3. Primary completionMay 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

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
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03387280
Sponsor's protocol ID
20170821B
Status last verified
Apr 2018
First submitted
21 Dec 2017
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Blanke H, Cohen M, Schlueter GU, Karsch KR, Rentrop KP. Electrocardiographic and coronary arteriographic correlations during acute myocardial infarction. Am J Cardiol. 1984 Aug 1;54(3):249-55. doi: 10.1016/0002-9149(84)90176-0.

    PubMed 6464999
  • Berger PB, Ryan TJ. Inferior myocardial infarction. High-risk subgroups. Circulation. 1990 Feb;81(2):401-11. doi: 10.1161/01.cir.81.2.401. No abstract available.

    PubMed 2404629
  • Braat SH, Brugada P, den Dulk K, van Ommen V, Wellens HJ. Value of lead V4R for recognition of the infarct coronary artery in acute inferior myocardial infarction. Am J Cardiol. 1984 Jun 1;53(11):1538-41. doi: 10.1016/0002-9149(84)90575-7.

    PubMed 6731298
  • Braat SH, de Zwaan C, Brugada P, Coenegracht JM, Wellens HJ. Right ventricular involvement with acute inferior wall myocardial infarction identifies high risk of developing atrioventricular nodal conduction disturbances. Am Heart J. 1984 Jun;107(6):1183-7. doi: 10.1016/0002-8703(84)90275-8.

    PubMed 6326559
  • Bueno H, Lopez-Palop R, Bermejo J, Lopez-Sendon JL, Delcan JL. In-hospital outcome of elderly patients with acute inferior myocardial infarction and right ventricular involvement. Circulation. 1997 Jul 15;96(2):436-41. doi: 10.1161/01.cir.96.2.436.

    PubMed 9244209
  • Bueno H, Lopez-Palop R, Perez-David E, Garcia-Garcia J, Lopez-Sendon JL, Delcan JL. Combined effect of age and right ventricular involvement on acute inferior myocardial infarction prognosis. Circulation. 1998 Oct 27;98(17):1714-20. doi: 10.1161/01.cir.98.17.1714.

    PubMed 9788824
  • Mehta SR, Eikelboom JW, Natarajan MK, Diaz R, Yi C, Gibbons RJ, Yusuf S. Impact of right ventricular involvement on mortality and morbidity in patients with inferior myocardial infarction. J Am Coll Cardiol. 2001 Jan;37(1):37-43. doi: 10.1016/s0735-1097(00)01089-5.

    PubMed 11153770
  • Assali AR, Teplitsky I, Ben-Dor I, Solodky A, Brosh D, Battler A, Fuchs S, Kornowski R. Prognostic importance of right ventricular infarction in an acute myocardial infarction cohort referred for contemporary percutaneous reperfusion therapy. Am Heart J. 2007 Feb;153(2):231-7. doi: 10.1016/j.ahj.2006.10.038.

    PubMed 17239681
  • Hamon M, Agostini D, Le Page O, Riddell JW, Hamon M. Prognostic impact of right ventricular involvement in patients with acute myocardial infarction: meta-analysis. Crit Care Med. 2008 Jul;36(7):2023-33. doi: 10.1097/CCM.0b013e31817d213d.

    PubMed 18552681
  • Owens CG, McClelland AJ, Walsh SJ, Smith BA, Stevenson M, Khan MM, Adgey JA. In-hospital percutaneous coronary intervention improves in-hospital survival in patients with acute inferior myocardial infarction particularly with right ventricular involvement. J Invasive Cardiol. 2009 Feb;21(2):40-4.

    PubMed 19182288
  • Assali AR, Herz I, Vaturi M, Adler Y, Solodky A, Birnbaum Y, Sclarovsky S. Electrocardiographic criteria for predicting the culprit artery in inferior wall acute myocardial infarction. Am J Cardiol. 1999 Jul 1;84(1):87-9, A8. doi: 10.1016/s0002-9149(99)00197-6.

    PubMed 10404857
  • Herz I, Assali AR, Adler Y, Solodky A, Sclarovsky S. New electrocardiographic criteria for predicting either the right or left circumflex artery as the culprit coronary artery in inferior wall acute myocardial infarction. Am J Cardiol. 1997 Nov 15;80(10):1343-5. doi: 10.1016/s0002-9149(97)00678-4.

    PubMed 9388111
  • Zimetbaum PJ, Josephson ME. Use of the electrocardiogram in acute myocardial infarction. N Engl J Med. 2003 Mar 6;348(10):933-40. doi: 10.1056/NEJMra022700. No abstract available.

    PubMed 12621138
  • Bayram E, Atalay C. Identification of the culprit artery involved in inferior wall acute myocardial infarction using electrocardiographic criteria. J Int Med Res. 2004 Jan-Feb;32(1):39-44. doi: 10.1177/147323000403200106.

    PubMed 14997704
  • Fiol M, Cygankiewicz I, Carrillo A, Bayes-Genis A, Santoyo O, Gomez A, Bethencourt A, Bayes de Luna A. Value of electrocardiographic algorithm based on "ups and downs" of ST in assessment of a culprit artery in evolving inferior wall acute myocardial infarction. Am J Cardiol. 2004 Sep 15;94(6):709-14. doi: 10.1016/j.amjcard.2004.05.053.

    PubMed 15374771

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, of Inferolateral Wall and Acute Myocardial Infarction, of Inferoposterior Wall, run by Yuan's 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 12 Apr 2018. 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 Ting-Yu Su, MS (886-73351121 ext. 1601, irb@yuanhosp.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

determine which criteria is the best one in predicting the culprit site (time frame: about 1-2 months). 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 NCT03387280, which also lists 25 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 12 Apr 2018.

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