Coronary AngiographyPhase 4NCT01239225
Prevalence of Abdominal Aortic Aneurysm in Patients Undergoing Coronary Angiography
A Phase 4 study testing Abdominal ultra-sound and Abdominal ultrasound in people with Coronary Angiography, run by Meir Medical Center.
Trial summary
Abdominal aortic aneurysms (AAA) are localized, blood-filled dilations (balloon-like bulges) of the aorta. Approximately 90% of abdominal aortic aneurysms occur infrarenally (1). It is most commonly asymptomatic and can be detected randomly during screening. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography
- What is being tested?
- Abdominal ultra-sound and Abdominal ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 4
- 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
- Adult, Older adult
Who may be able to join
- Subject is ≥ 18 years of age.
- Subject understands study requirements and diagnostic procedures and agrees to sign an informed consent form prior to both study procedures:
- Ultrasonographic screening of abdominal aorta (from diaphragm to aorta bifurcation) in horizontal and vertical position for the detection of aneurysms. Ultrasonographic screening will be perform in frontal technique for sagital view and in right lateral decubitus for coronal view. The outer aortic diameter will be measured in three levels: at the level of the diaphragm, at SMA level and proximal to the aorta bifurcation.
- Coronary angiography.
- The patients will be divided into two groups according to the results of their angiograms:
- Normal coronary angiography (n=100).
- Atherosclerosis of coronary arteries (n=100).
- Subject will be available for ultrasonographic follow-up after the procedure.
Who cannot join
- Pregnancy.
- Subject has systemic infection, or is suspected of having systemic infection.
- Subject has an untreatable bleeding.
- Enrollment in another study protocol.
About this study
Abdominal aortic aneurysms (AAA) are localized, blood-filled dilations (balloon-like bulges) of the aorta. Approximately 90% of abdominal aortic aneurysms occur infrarenally (1). It is most commonly asymptomatic and can be detected randomly during screening. Its prevalence rate in men aged 65 years and more is 5 - 8% (3).
The risk factors for the occurrence of AAA are male gender, advanced age, history of atherosclerosis, cigarette smoking and 1st degree family history (4).
Read more
The prevalence rate is higher in patients with history of atherosclerosis of peripheral blood vessels and coronary arteries (5 - 7). As the size of an aneurysm increases, there is an increased risk of rupture, which can result in severe hemorrhage and death. The death rate due to rupture in the elderly population is 90% (3, 8). Elective surgical repair of the abdominal aortic aneurysm is associated with a death rate of 8% (9). Therefore, the importance of the screening of populations at elevated risk is obvious (5 - 7, 10 -14). Among imaging techniques, ultrasonographic screening for abdominal aortic aneurysm is technically simple, accurate and devoid of ionizing radiation. Ultrasonographic diagnosis of AAA is associated with a major reduction in the incidence of abdominal aortic aneurysm-related mortality (15 - 19). The sensitivity of ultrasonographic screening for abdominal aortic aneurysm is about 100% (19). The most common clinical indications for ultrasonographic screening for abdominal aortic aneurysm are a palpable abdominal mass, hemodynamic impairment of aortic system in lower extremities, pain in the chest, lower back or scrotum, and abdominal bruits.
Ultrasonography is used to screen for aneurysms when the outer aortic diameter is more than 3 cm (normal diameter of the aorta is around 2 cm (20). There is disagreement regarding the follow-up of patients after detection of abdominal aortic aneurysm in diameter of 2.6 cm - 2.9 cm (22). Random detection of abdominal aortic aneurysm where the aortic diameter is 2.6 cm, in men aged 65 years and more, have been associated with no risk for its future significant development (21). Ultrasonographic evaluation of abdominal aorta is a challenge for clinicians because of the need for the accurate detection of aortic diameter (20).
- Conditions
- Coronary Angiography
- Being tested
- Abdominal ultra-sound, Abdominal ultrasound
- Keywords
- Patients undergoing coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultra-soundDevice
Abdominal ultrasoundProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Abdominal ultrasound | Experimental | Abdominal ultrasound Receives: Device: Abdominal ultra-sound; Procedure: Abdominal ultrasound |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngiographyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239225
- Sponsor's protocol ID
- mmc2010137-09ctil
- Status last verified
- Oct 2010
- First submitted
- 7 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Abdominal Aortic Aneurysm in Patients Undergoing Coronary Angiography
- ClinicalTrials.gov ID
- NCT01239225
- Acronym / sponsor ID
- mmc2010137-09ctil
- Conditions
- Coronary Angiography
- Keywords
- Patients undergoing coronary angiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- First posted
- 11 Nov 2010 (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.
Abdominal aortic aneurysms (AAA) are localized, blood-filled dilations (balloon-like bulges) of the aorta. Approximately 90% of abdominal aortic aneurysms occur infrarenally (1). It is most commonly asymptomatic and can be detected randomly during screening. Its prevalence rate in men aged 65 years and more is 5 - 8% (3).
The risk factors for the occurrence of AAA are male gender, advanced age, history of atherosclerosis, cigarette smoking and 1st degree family history (4).
The prevalence rate is higher in patients with history of atherosclerosis of peripheral blood vessels and coronary arteries (5 - 7). As the size of an aneurysm increases, there is an increased risk of rupture, which can result in severe hemorrhage and death. The death rate due to rupture in the elderly population is 90% (3, 8). Elective surgical repair of the abdominal aortic aneurysm is associated with a death rate of 8% (9). Therefore, the importance of the screening of populations at elevated risk is obvious (5 - 7, 10 -14). Among imaging techniques, ultrasonographic screening for abdominal aortic aneurysm is technically simple, accurate and devoid of ionizing radiation. Ultrasonographic diagnosis of AAA is associated with a major reduction in the incidence of abdominal aortic aneurysm-related mortality (15 - 19). The sensitivity of ultrasonographic screening for abdominal aortic aneurysm is about 100% (19). The most common clinical indications for ultrasonographic screening for abdominal aortic aneurysm are a palpable abdominal mass, hemodynamic impairment of aortic system in lower extremities, pain in the chest, lower back or scrotum, and abdominal bruits.
Ultrasonography is used to screen for aneurysms when the outer aortic diameter is more than 3 cm (normal diameter of the aorta is around 2 cm (20). There is disagreement regarding the follow-up of patients after detection of abdominal aortic aneurysm in diameter of 2.6 cm - 2.9 cm (22). Random detection of abdominal aortic aneurysm where the aortic diameter is 2.6 cm, in men aged 65 years and more, have been associated with no risk for its future significant development (21). Ultrasonographic evaluation of abdominal aorta is a challenge for clinicians because of the need for the accurate detection of aortic diameter (20).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal ultrasound | Experimental | Device: Abdominal ultra-sound, Procedure: Abdominal ultrasoundAbdominal ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is ≥ 18 years of age.
- Subject understands study requirements and diagnostic procedures and agrees to sign an informed consent form prior to both study procedures:
- The patients will be divided into two groups according to the results of their angiograms:
Key exclusion criteria (4 listed)
- Pregnancy.
- Subject has systemic infection, or is suspected of having systemic infection.
- Subject has an untreatable bleeding.
- Enrollment in another study protocol.
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 |
|---|---|---|
| Abdominal ultra-sound | Device | Abdominal ultrasound |
| Abdominal ultrasound | Procedure or surgery | Abdominal ultrasound |
Primary outcome
Not reported in the source record.
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 11 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abdominal ultra-sound and Abdominal ultrasound in people with Coronary Angiography, run by Meir Medical Center.
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 8 inclusion and 4 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 11 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 11 Nov 2010.