Acute Coronary SyndromeNCT01863524
Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography Among Patients With Acute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial summary
The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%. when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in women. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 90 participants
- Where
- 2 sitesIsrael
- Study dates
- May 2013to Jul 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients over 65 years old with ACS admitted in Intensive Cardiac Care Unit, who will be examined by TTE.
Who may be able to join
- patients over 65 years old with ACS. patients capable of reading, understanding and signing informed concent
Who cannot join
- suboptimal TTE windows
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
HaEmek MC Cardiology depratment
Afula, 18100
Haemek Medical Center
Afula
About this study
Official title: Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography (TTE) Among Patients With Acute Coronary Syndrome in Intensive Cardiac Care Unit.
The prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%. when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in women.
As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients with acute coronary syndrome represent a high risk population in which screening for another atherosclerotic site is recommended.
Read more
Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the opportunity to evaluate the cardiac morphology and function and to screen for Abdominal Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique was between 91-96% for AAA screening.
In addition, this method is cheap, available and requires only 2-3 minutes to be added to the standard TTE.
we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by TTE in subcostal views in addition to the standard TTE examination.
- Conditions
- Acute Coronary Syndrome
- Keywords
- Abdominal Aortic Aneurysm (AAA),, Echocardiography (TTE),, Acute Coronary Syndrome (ACS), Patients over 65 years old
- Medical subject headings
- Acute Coronary Syndrome, Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal aortic diameter measurement of 30 mm or more by portable transthoracic echocardiography, will be defined as abdominal aortic aneurysm.
Measured: Average time period of 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies 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
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Jabaren, HaEmek Medical Center, Israel
- Investigators
- Mohamad Jabaren, MD, Principal investigator, Haemek Medical Center, Afula, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863524
- Sponsor's protocol ID
- emc130152ctil
- Status last verified
- Dec 2016
- First submitted
- 14 May 2013
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Abdominal Aortic Aneurysm Using a Portable Transthoracic Echocardiography (TTE) Among Patients With Acute Coronary Syndrome in Intensive Cardiac Care Unit.
- ClinicalTrials.gov ID
- NCT01863524
- Acronym / sponsor ID
- emc130152ctil
- Conditions
- Acute Coronary Syndrome
- Keywords
- Abdominal Aortic Aneurysm (AAA),, Echocardiography (TTE),, Acute Coronary Syndrome (ACS), Patients over 65 years old
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 May 2013 (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 prevalence of Abdominal Aortic Aneurysm among 65 years old individuals worldwide is 1-2%. when diagnosis is confirmed by abdominal Ultrasound the prevalence is 5.5% in men and 1% in women.
As abdominal aortic aneurysm and coronary heart disease share common risk factors, patients with acute coronary syndrome represent a high risk population in which screening for another atherosclerotic site is recommended.
Patients admitted for ACS undergo routinely TTE. during the same study, TTE may offer the opportunity to evaluate the cardiac morphology and function and to screen for Abdominal Aortic aneurysm. It was reported by different studies that the Sensitivity of this technique was between 91-96% for AAA screening.
In addition, this method is cheap, available and requires only 2-3 minutes to be added to the standard TTE.
we plan to examine patients admitted with ACS in our Intensive Care Unit for screening AAA by TTE in subcostal views in addition to the standard TTE examination.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients over 65 years old with ACS admitted in Intensive Cardiac Care Unit, who will be examined by TTE.
Key inclusion criteria (1 listed)
- patients over 65 years old with ACS. patients capable of reading, understanding and signing informed concent
Key exclusion criteria (1 listed)
- suboptimal TTE windows
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
Abdominal aortic diameter measurement of 30 mm or more by portable transthoracic echocardiography, will be defined as abdominal aortic aneurysm.
Time frame: Average time period of 72 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Mohamad Jabaren, MD principal investigator
Haemek Medical Center, Afula, Israel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by HaEmek Medical Center, Israel at 2 sites in Israel.
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: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal aortic diameter measurement of 30 mm or more by portable transthoracic echocardiography, will be defined as abdominal aortic aneurysm. (time frame: Average time period of 72 hours.). 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 Dec 2016.