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.
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
- Conditions the study is for
- Coronary Artery Disease, Acute Myocardial Infarction, Acute Myocardial Infarction of Anterior Wall
- 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.
George Juang, MD contact
United States1 site, 1 recruiting
- Recruiting
Coney Island Hospital
Brooklyn, New York, 11235
Ida H Suen, MD, 941-228-9020, is2148@gmail.com
Ida H Suen, MD
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)
- Conditions
- Coronary Artery Disease, Acute Myocardial Infarction, Acute Myocardial Infarction of Anterior Wall, Collateral Circulation, Any Site
- 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 group | Role | What they receive |
|---|---|---|
| LAD with collaterals with and without wellens sign | Not described Receives: Other: Wellens Sign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Oct 2018
- Study start26 Sep 2018
- Primary completion23 Jun 2019 (estimated)
- Study completion23 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coney Island Hospital, Brooklyn, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Juang, Coney Island Hospital, Brooklyn, NY
- Investigators
- George Juang, MD, Principal investigator, Coney Island Hospital
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 6121481Haines 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 6602539Yaylak 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 26689135Gohlke 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 2035435Freedman 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 3971537Martinez-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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Coronary Collateral Circulation Mask the Presence of a Wellens Sign in Patients With Critical Stenosis of the Left Anterior Descending Artery?
- ClinicalTrials.gov ID
- NCT03707626
- Acronym / sponsor ID
- 18-08-283-378(HHC)
- Conditions
- Coronary Artery Disease, Acute Myocardial Infarction, Acute Myocardial Infarction of Anterior Wall, Collateral Circulation, Any Site
- Keywords
- wellens sign, coronary collateral circulation, acute myocardial infarction, left anterior descending artery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Coney Island Hospital, Brooklyn, NYUniversity, hospital or other
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 23 Jun 2019 (estimated)
- Study completion
- 23 Jun 2019 (estimated)
- First posted
- 16 Oct 2018 (actual)
- 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.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAD with collaterals with and without wellens sign | – | Other: Wellens Sign |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- All patients receiving cardiac catheterization between 2003-2016 at Coney Island Hospital with LAD lesions and pre-catheterization electrocardiograms.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Wellens Signpresence or absence in presence of coronary collaterals to LAD | Other | LAD with collaterals with and without wellens sign |
Primary outcome
Wellens Sign
Time frame: 2003-2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Background: PubMed 6121481de 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.
- Background: PubMed 6602539Haines 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.
- Background: PubMed 26689135Yaylak 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.
- Background: PubMed 2035435Gohlke 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.
- Background: PubMed 3971537Freedman 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.
- Background: PubMed 5443910Martinez-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.
- Individual participant dataSharing planned: No
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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.
George Juang, MD contact
George Juang, MD principal investigator
Coney Island Hospital
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 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.