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Collateral Circulation to LAD and Wellens Sign

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707626
Recruitment Status : Unknown
Verified October 2018 by George Juang, Coney Island Hospital, Brooklyn, NY.
Recruitment status was:  Recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
George Juang, Coney Island Hospital, Brooklyn, NY

Brief 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. 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.


Condition or disease Intervention/treatment
Coronary Artery Disease Acute Myocardial Infarction Acute Myocardial Infarction of Anterior Wall Collateral Circulation, Any Site Other: Wellens Sign

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Does Coronary Collateral Circulation Mask the Presence of a Wellens Sign in Patients With Critical Stenosis of the Left Anterior Descending Artery?
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : June 23, 2019
Estimated Study Completion Date : June 23, 2019

Group/Cohort Intervention/treatment
LAD with collaterals with and without wellens sign Other: Wellens Sign
presence or absence in presence of coronary collaterals to LAD




Primary Outcome Measures :
  1. Wellens Sign [ Time Frame: 2003-2016 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707626


Contacts
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Contact: Ida H Suen, MD 9412289020 is2148@gmail.com
Contact: George Juang, MD

Locations
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United States, New York
Coney Island Hospital Recruiting
Brooklyn, New York, United States, 11235
Contact: Ida H Suen, MD    941-228-9020    is2148@gmail.com   
Sub-Investigator: Ida H Suen, MD         
Principal Investigator: George Juang, MD         
Sub-Investigator: Adil Ali, MD         
Sponsors and Collaborators
Coney Island Hospital, Brooklyn, NY
Investigators
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Principal Investigator: George Juang, MD Coney Island Hospital
Publications:
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Responsible Party: George Juang, Primary Investigator, Coney Island Hospital, Brooklyn, NY
ClinicalTrials.gov Identifier: NCT03707626    
Other Study ID Numbers: 18-08-283-378(HHC)
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by George Juang, Coney Island Hospital, Brooklyn, NY:
wellens sign
coronary collateral circulation
acute myocardial infarction
left anterior descending artery
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases