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Coronary Artery DiseaseNCT03707626

Collateral Circulation to LAD and Wellens Sign

An observational study of Coronary Artery Disease and Acute Myocardial Infarction, run by Coney Island Hospital, Brooklyn, NY at 1 site in United States.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Overall Aim Coronary artery disease significantly contributes to morbidity and mortality in the United States. Atherosclerotic disease can lead to stenosis of the coronary arteries and subsequent cardiac hypoperfusion. Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
Wellens Sign
How many people
1,500 participants
Where
1 siteUnited States
Study dates
26 Sep 2018to 23 Jun 2019
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 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients of Coney Island Hospital between ages 18-89 years old between years of 2003-2016 receiving cardiac catheterization with pre-catheterization electrocardiograms

Who may be able to join

  • All patients receiving cardiac catheterization between 2003-2016 at Coney Island Hospital with LAD lesions and pre-catheterization electrocardiograms.

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Ida H Suen, MD contact

9412289020

is2148@gmail.com

George Juang, MD contact

United States1 site, 1 recruiting
  • Coney Island Hospital

    Brooklyn, New York, 11235

    Ida H Suen, MD, 941-228-9020, is2148@gmail.com

    Ida H Suen, MD

    Recruiting

Other trials in United States

About this study

Official title: Does Coronary Collateral Circulation Mask the Presence of a Wellens Sign in Patients With Critical Stenosis of the Left Anterior Descending Artery?

Overall Aim Coronary artery disease significantly contributes to morbidity and mortality in the United States. Atherosclerotic disease can lead to stenosis of the coronary arteries and subsequent cardiac hypoperfusion. Patients with a critical stenosis of the LAD, potentially leading to acute anterior wall myocardial infarction, may be asymptomatic at presentation with subtle EKG changes as its only manifestation. It is imperative for physicians to recognize patients with new T wave inversions in leads V2-V3 as the standard course of management may lead to poor prognosis.

The purpose of this study is to determine if collateral circulation to the left anterior descending (LAD) artery will mask the presence of a Wellens sign and therefore diminish its diagnostic utility. The conclusion of this study would raise awareness for physicians in light of an absent Wellens sign.

Hypothesis The presence of coronary collateral circulation to the LAD masks the presence of a Wellens sign (both Type 1 and Type 2) in precordial leads V2-V4.

Read the detailed description

Introduction Electrocardiograms are an inexpensive and indispensible tool to assess cardiac rhythm and ischemia. A Wellens sign on an EKG is either a deeply inverted (Type 1) or biphasic (Type 2) t-wave in precordial leads V2-V3 (but may extend to other precordial leads). It is associated with critical stenosis of the proximal left anterior descending (LAD) artery. Patients with a Wellens sign are at high risk for extensive anterior wall myocardial infarction as the LAD is the main coronary artery that supplies the left ventricle. Exercise stress testing is contraindicated in this patient population. In addition, appropriate management of these patients is crucial to avoid acute myocardial infarction.

There have been a number of studies addressing the role of collateral coronary circulation in myocardial infarctions. Some studies show that the presence of collateral circulation is associated with improved in-hospital outcomes in patients following a ST-elevation myocardial infarction (STEMI) whereas others show that collateral circulation does not decrease morbidity and mortality in patients following acute STEMI. Similarly, patients with collateral circulation may have normal EKGs and be asymptomatic at rest but are symptomatic with corresponding abnormal EKG findings during periods of increased cardiac demand.

Patients with a critically stenosed LAD may be asymptomatic and have normal to minimally elevated cardiac enzymes at the time of presentation with at rest abnormal EKG findings being the sole clue to the patient's gravity. While some studies have shown collateral coronary circulation lead to normal EKGs, there is limited research addressing whether or not collateral circulation affects the presence of a Wellens sign. As a result, its diagnostic utility is questionable.

Overall Aim Coronary artery disease significantly contributes to morbidity and mortality in the United States. Atherosclerotic disease can lead to stenosis of the coronary arteries and subsequent cardiac hypoperfusion. Patients with a critical stenosis of the LAD, potentially leading to acute anterior wall myocardial infarction, may be asymptomatic at presentation with subtle EKG changes as its only manifestation. It is imperative for physicians to recognize patients with new T wave inversions in leads V2-V3 as the standard course of management may lead to poor prognosis.

The purpose of this study is to determine if collateral circulation to the left anterior descending (LAD) artery will mask the presence of a Wellens sign and therefore diminish its diagnostic utility. The conclusion of this study would raise awareness for physicians in light of an absent Wellens sign.

Study Objectives

To identify if coronary collateral circulation masks the presence of a Wellens sign by:

Evaluating catheterization reports Examining for the presence of coronary collateral circulation Examining EKGs for presence of deeply inverted t-waves in precordial leads Examining EKGs for presence of biphasic t-waves in precordial leads Correlating the presence/absence of coronary collateral circulation with EKG findings

Hypothesis:

The presence of coronary collateral circulation to the LAD masks the presence of a Wellens sign (both Type 1 and Type 2) in precordial leads V2-V4.

Study Design This study will be a retrospective chart review of patients who received cardiac catheterization and had LAD and/or Left Main lesions between the years 2000-2016 at Coney Island Hospital. Catheterization imaging and reports will be reviewed for collateral circulation. Subsequent pre-catheterization electrocardiograms, dated up to 1 year prior to cardiac catheterization, will be reviewed for the presence or absence of symmetrical deep (≥2 mV) t-wave inversion (type 1) or biphasic t-wave (type 2) Wellens sign in precordial leads. EKGs will be accessed either electronically or physically. All data will be de-identified and coded to maintain patient confidentiality.

What and how will you measure or collect data to test your hypothesis (or study objectives)? A retrospective chart review of cardiac catheterizations will be employed to assess the presence of coronary collateral circulation. Grading of coronary collateral circulation will be divided into four categories (0=no filling, 1=filling of side branches only, 2=partial filling of epicardial segments, 3=complete filling of epicardial segments). In addition, pre-catheterization EKGs will be analyzed for a.) the presence or absence of deeply inverted t-waves (type 1) or biphasic t-waves (type 2) and b.) the amplitude (mV) of each corresponding Wellens sign. Demographic data including medical record number, age, gender, and known risk factors, including but not limited to diabetes, smoking, drinking, previous myocardial infarction, hyperlipidemia, and hypertension, will be recorded for data analysis.

Describe where the research data will reside and who will have access to hold or maintain the data? Research data will be collected and recorded on a password protected Microsoft Excel Spreadsheet. Excel file will be saved on Coney Island Hospital servers. Computers are password protected and every effort will be made to ensure safekeeping of the aforementioned Excel file. File will be stored for a maximum of three years and will be permanantly eliminated following the conclusion and publication of proposed study.

Data will be managed by Dr. Ida Hui Suen and Dr. George Juang. Data will not be released to other collaborators. De-identified data will be forwarded to central office for assistance with statistical analysis if needed.

Describe the methods that will be used to destroy data and/or specimens at the end of the research study life cycle.

Efforts will be made to ensure that all files are deleted from Coney Island Servers. No specimens will be collected.

Data Analysis Statistical analysis will be performed with the assistance of Brian Altonen of New York Health and Hospital Corporation's Central Office. Chi Square, ANOVA, and multiple logistic regression analyses will be applied.

Sample Size Approximately 6,000 patients received cardiac catheterizations at Coney Island Hospital between 2003-2016. Approximately 30% will have LAD lesions (N=1800); of which approximately 20% will have a Wellens sign (N=360).

Variables Age, Nominal Sex, Categorical (1=M, 2=F) Date of Catheterization Location of Lesion, Categorical (1=LAD Proximal, 2=LAD Mid, 3=LAD Distal, 4=Left Main) Collaterals present, Categorical (0=N, 1=Y) Grading of Collaterals, Categorical (0=none, 1= filling of side branches, 2=partial filling of epicardial segment, 3=complete filling of epicardial segment) Date of pre-cath EKG Wellens Sign Present, Categorical (1=Y, 2=N) Type of Wellens Sign, Categorical (1=Type 1, 2=Type 2)

Being tested
Wellens Sign
Keywords
wellens sign, coronary collateral circulation, acute myocardial infarction, left anterior descending artery
Medical subject headings
Coronary Artery Disease, Anterior Wall Myocardial Infarction

What participants receive

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

  • Wellens SignOther

    presence or absence in presence of coronary collaterals to LAD

Study groups in NCT03707626
Study groupRoleWhat they receive
LAD with collaterals with and without wellens signNot described
Receives: Other: Wellens Sign

What is being measured

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

  1. Wellens Sign

    Measured: 2003-2016

Timeline

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

  1. First posted16 Oct 2018
  2. Study start26 Sep 2018
  3. Primary completion23 Jun 2019 (estimated)
  4. Study completion23 Jun 2019 (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
Cohort
Time perspective
Retrospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03707626
Sponsor's protocol ID
18-08-283-378(HHC)
Status last verified
Oct 2018
First submitted
12 Oct 2018
Last updated
16 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • de Zwaan C, Bar FW, Wellens HJ. Characteristic electrocardiographic pattern indicating a critical stenosis high in left anterior descending coronary artery in patients admitted because of impending myocardial infarction. Am Heart J. 1982 Apr;103(4 Pt 2):730-6. doi: 10.1016/0002-8703(82)90480-x.

    PubMed 6121481
  • Haines DE, Raabe DS, Gundel WD, Wackers FJ. Anatomic and prognostic significance of new T-wave inversion in unstable angina. Am J Cardiol. 1983 Jul;52(1):14-8. doi: 10.1016/0002-9149(83)90061-9.

    PubMed 6602539
  • Yaylak B, Altintas B, Ede H, Baysal E, Akyuz S, Bilge O, Sevuk U, Erdogan G, Ciftci H. Impact of Coronary Collateral Circulation on In-Hospital Death in Patients with Inferior ST Elevation Myocardial Infarction. Cardiol Res Pract. 2015;2015:242686. doi: 10.1155/2015/242686. Epub 2015 Nov 25.

    PubMed 26689135
  • Gohlke H, Heim E, Roskamm H. Prognostic importance of collateral flow and residual coronary stenosis of the myocardial infarct artery after anterior wall Q-wave acute myocardial infarction. Am J Cardiol. 1991 Jun 1;67(15):1165-9. doi: 10.1016/0002-9149(91)90920-g.

    PubMed 2035435
  • Freedman SB, Dunn RF, Bernstein L, Morris J, Kelly DT. Influence of coronary collateral blood flow on the development of exertional ischemia and Q wave infarction in patients with severe single-vessel disease. Circulation. 1985 Apr;71(4):681-6. doi: 10.1161/01.cir.71.4.681.

    PubMed 3971537
  • Martinez-Rios MA, Da Costa BC, Cecena-Seldner FA, Gensini GG. Normal electrocardiogram in the presence of severe coronary artery sease. Am J Cardiol. 1970 Mar;25(3):320-4. doi: 10.1016/s0002-9149(70)80009-1. No abstract available.

    PubMed 5443910

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Acute Myocardial Infarction, run by Coney Island Hospital, Brooklyn, NY 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 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 16 Oct 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ida H Suen, MD (9412289020, is2148@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wellens Sign (time frame: 2003-2016). 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 NCT03707626, which also lists 6 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 16 Oct 2018.

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