Ekg Change Ischemia LateralECGNCT02027506
Diagnostic Value of Electrocardiographic St-t Wave Changes in Patients With Chronic Stable Angina
An observational study of Ekg Change Ischemia Lateral, run by Alexandria University at 1 site in Egypt.
Trial summary
The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a well-established role in the diagnosis of (CAD). Many studies have found that the admission of ECG provides important prognostic information in patients admitted with chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ekg Change Ischemia Lateral
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2014to Jan 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will be a prospective observational study conducted on 150 patients admitted at the Alexandria university hospitals or referred from secondary hospitals with documented CAD as proved by non invasive tests (ECG, echocardiography, treadmill exercise, myocardial perfusion imaging or multi-slice CT coronary angiography) requiring invasive coronary angiography.
Who may be able to join
- patients admitted at the Alexandria university hospitals or referred from secondary hospitals with documented CAD as proved by non invasive tests
Who cannot join
- Clinical situations that may result in secondary aVL lead T wave inversion and /or ST segment depression from analysis as Bundle branch block either left or right, aortic stenosis, left ventricular hypertrophy and strain and paced ventricular rhythms.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Alexandria Medical College
Alexandria
A Y ZEID, 00201008676464, awadyoussef@yahoo.com
About this study
Official title: DIAGNOSTIC VALUE OF ELECTROCARDIOGRAPHIC ST-T WAVE CHANGES IN LEAD aVL IN PATIENTS WITH CHRONIC STABLE ANGINA
The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a well-established role in the diagnosis of (CAD). Many studies have found that the admission of ECG provides important prognostic information in patients admitted with chest pain. For instance, T wave inversion in anterior or inferior location and or ST-segment depression has been associated with high incidence of CAD.
Read the detailed description
The aim of the work will be directed to study the diagnostic value of electrocardiographic ST-T wave changes in lead aVL in patients with chronic stable angina
The ECG findings vary considerably, depending importantly on four major factors: (1) the duration of the ischemic process (acute versus evolving or chronic) ; (2) its extent (large versus small) ; (3) its topography (anterior versus inferior-posterior and right ventricular) ; (4) the presence of other underlying conditions (e.g. LBBB, WPW or pacemaker pattern) that can mask or alters the classic pattern.
The resting electrocardiogram is normal in approximately half of patients with chronic stable angina pectoris, and even patients with severe CAD may have a normal tracing at rest. A normal resting ECG suggesting a normal LV function and it is unusual finding in a patient with an extensive previous infarction.
The most common electrocardiographic abnormalities in patients with chronic CAD are non specific ST-Twave changes with or without abnormal Q waves. In addition to myocardial ischemia, other conditions that can produce ST-T wave abnormalities include LV hypertrophy or dilation, electrolyte abnormalities, neurogenic effects, and anti-arrhythmic drugs.
In patients with known CAD, however, the occurrence of ST-T wave abnormalities on the resting ECG may correlate with the severity of the underlying heart disease. This association may explain the adverse association of ST-Twave changes with prognosis of these patients. In contrast, a normal resting ECG is more favorable long-term prognostic sign in patients with suspected or definite CAD.
- Conditions
- Ekg Change Ischemia Lateral
- Keywords
- ECG, aVL, CHRONIC STABLE ANGINA, T WAVE
- Medical subject headings
- Angina, Stable
What is being measured
The primary outcome is the main question the study is designed to answer.
Corelation between ecg finding and coronary angiography finding
the value of t wave and st segment changes in correlation with the cornary angiographic findings
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014 (estimated)
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ekg Change Ischemia LateralStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Awad Youssef Awad Zeid, Alexandria University
- Investigators
- A Y zeid, M.B,CH.B., Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027506
- Sponsor's protocol ID
- dvavl2185
- Acronym
- ECG
- Status last verified
- Jan 2014
- First submitted
- 3 Jan 2014
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAGNOSTIC VALUE OF ELECTROCARDIOGRAPHIC ST-T WAVE CHANGES IN LEAD aVL IN PATIENTS WITH CHRONIC STABLE ANGINA
- ClinicalTrials.gov ID
- NCT02027506
- Acronym / sponsor ID
- ECG / dvavl2185
- Conditions
- Ekg Change Ischemia Lateral
- Keywords
- ECG, aVL, CHRONIC STABLE ANGINA, T WAVE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 6 Jan 2014 (estimated)
- 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.
The electrocardiogram (ECG) is a simple and non-invasive bedside diagnostic tool with a well-established role in the diagnosis of (CAD). Many studies have found that the admission of ECG provides important prognostic information in patients admitted with chest pain. For instance, T wave inversion in anterior or inferior location and or ST-segment depression has been associated with high incidence of CAD.
Detailed description
The aim of the work will be directed to study the diagnostic value of electrocardiographic ST-T wave changes in lead aVL in patients with chronic stable angina
The ECG findings vary considerably, depending importantly on four major factors: (1) the duration of the ischemic process (acute versus evolving or chronic) ; (2) its extent (large versus small) ; (3) its topography (anterior versus inferior-posterior and right ventricular) ; (4) the presence of other underlying conditions (e.g. LBBB, WPW or pacemaker pattern) that can mask or alters the classic pattern.
The resting electrocardiogram is normal in approximately half of patients with chronic stable angina pectoris, and even patients with severe CAD may have a normal tracing at rest. A normal resting ECG suggesting a normal LV function and it is unusual finding in a patient with an extensive previous infarction.
The most common electrocardiographic abnormalities in patients with chronic CAD are non specific ST-Twave changes with or without abnormal Q waves. In addition to myocardial ischemia, other conditions that can produce ST-T wave abnormalities include LV hypertrophy or dilation, electrolyte abnormalities, neurogenic effects, and anti-arrhythmic drugs.
In patients with known CAD, however, the occurrence of ST-T wave abnormalities on the resting ECG may correlate with the severity of the underlying heart disease. This association may explain the adverse association of ST-Twave changes with prognosis of these patients. In contrast, a normal resting ECG is more favorable long-term prognostic sign in patients with suspected or definite CAD.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will be a prospective observational study conducted on 150 patients admitted at the Alexandria university hospitals or referred from secondary hospitals with documented CAD as proved by non invasive tests (ECG, echocardiography, treadmill exercise, myocardial perfusion imaging or multi-slice CT coronary angiography) requiring invasive coronary angiography.
Key inclusion criteria (1 listed)
- patients admitted at the Alexandria university hospitals or referred from secondary hospitals with documented CAD as proved by non invasive tests
Key exclusion criteria (1 listed)
- Clinical situations that may result in secondary aVL lead T wave inversion and /or ST segment depression from analysis as Bundle branch block either left or right, aortic stenosis, left ventricular hypertrophy and strain and paced ventricular rhythms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corelation between ecg finding and coronary angiography finding
Time frame: 9 months
the value of t wave and st segment changes in correlation with the cornary angiographic findings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
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.
A Y zeid, M.B,CH.B. principal investigator
Alexandria University
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 Ekg Change Ischemia Lateral, run by Alexandria University at 1 site in Egypt.
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 6 Jan 2014. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corelation between ecg finding and coronary angiography finding (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2014.