NCT03707626

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2018

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2019

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

9 months

First QC Date

October 12, 2018

Last Update Submit

October 12, 2018

Conditions

Keywords

wellens signcoronary collateral circulationacute myocardial infarctionleft anterior descending artery

Outcome Measures

Primary Outcomes (1)

  • Wellens Sign

    2003-2016

Study Arms (1)

LAD with collaterals with and without wellens sign

Other: Wellens Sign

Interventions

presence or absence in presence of coronary collaterals to LAD

LAD with collaterals with and without wellens sign

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coney Island Hospital

Brooklyn, New York, 11235, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 6121481BACKGROUND
  • 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.

    PMID: 6602539BACKGROUND
  • 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.

    PMID: 26689135BACKGROUND
  • 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.

    PMID: 2035435BACKGROUND
  • 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.

    PMID: 3971537BACKGROUND
  • 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.

    PMID: 5443910BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseAnterior Wall Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • George Juang, MD

    Coney Island Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ida H Suen, MD

CONTACT

George Juang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 16, 2018

Study Start

September 26, 2018

Primary Completion

June 23, 2019

Study Completion

June 23, 2019

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations