Carotid Artery DiseasesNCT03516929
Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to CABG
A study testing carotid duplex, both LL arterial duplex in people with Carotid Artery Diseases and Peripheral Artery Disease, run by Mr Ihab Ali at 1 site in Egypt.
Trial summary
From our experience among Egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Carotid Artery Diseases, Peripheral Artery Disease
- What is being tested?
- carotid duplex, both LL arterial duplex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2018to 10 May 2020
- Phase
- Interventional
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The acceptance of the patients to participate in the study in the form of a written consent.
- Patients of both sexes.
- Three vessels disease for CABG.
- Patients' age: from 35 to 75 years old.
- Elective, isolated, primary cases of CABG.
- Patients with ejection fraction above 40%.
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- Inclusion criteria for the high-risk group will include:
- Patients with preoperative history of cerebrovascular events or symptoms suggestive of CVS eg.TIA, transient blindness in one eye, Dizziness, Confusion, Drowsiness, Headache, Temporary inability to speak or move.
- Carotid bruit
- Left main stem coronary artery disease
- Presence of other peripheral vascular disease
Who cannot join
- Patients refusing to participate in the study.
- Age 76 years or above
- Morbid obese patients (body mass index more than 35).
- Patients who underwent coronary stenting before.
- Patients who underwent previous cardiac operation before.
- Patients with impaired renal functions (serum creatinine > 1.5 mg/dl, blood urea > 100 mg/dl and K+ > 5 meq/L).
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- Patients with preoperative hemoglobin < 9 gm/dl, white blood cells > 15,000 cells/mcl,platelets count < 140,000 per microliter.
- Patients with rhythm defects by electrocardiography (ECG).
- Patients with preoperative O2 saturation < 90 % by pulse oximetry.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-selective Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to Coronary Artery Bypass Surgery
From our experience among Egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. Thus, increasing the risk of post-operative morbid complications.We aim to evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a prospective, non-randomized, comparative study including two groups of patients. The study will start from the day of approval of the ethical committee. It will include 260 patients, on basis of "all new comers". Patients will be examined and classified as "high-risk" group (ɳ = 130) or "low-risk" group (ɳ=130).
All patients will have the "routine" preoperative investigations along with evaluation of extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by non-invasive bilateral lower limb arterial duplex.
- Conditions
- Carotid Artery Diseases, Peripheral Artery Disease
- Being tested
- carotid duplex, both LL arterial duplex
- Keywords
- carotid, peripheral arterial disease, endarterectomy
- Medical subject headings
- Carotid Artery Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carotid duplex, both LL arterial duplexDiagnostic test
assessment of carotid stenosis and lower limb peripheral ischemia.
| Study group | Role | What they receive |
|---|---|---|
| high risk group | Active comparator | history of stroke or TIA, carotid bruit, left main stem disease, other peripheral vascular disease Receives: Diagnostic Test: carotid duplex, both LL arterial duplex |
| low risk group | Sham comparator | No history or stroke,TIA. NO left main stem disease Receives: Diagnostic Test: carotid duplex, both LL arterial duplex |
What is being measured
The primary outcome is the main question the study is designed to answer.
culprit pathology in carotid and / or lower limb duplex
Measured: 6 months
Secondary outcomes (1)
new cerebrovascular event or lower limb ischemia in the post operative period
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start5 Aug 2018
- Primary completion25 Apr 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid Artery DiseasesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mr Ihab Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mr Ihab Ali, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516929
- Sponsor's protocol ID
- FMASU R 25/2018
- Status last verified
- May 2020
- First submitted
- 24 Apr 2018
- Last updated
- 26 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali I, Shokri H, Abd Al Jawad M. Assessment of carotid artery stenosis and lower limb peripheral ischemia before coronary artery bypass grafting operations: a non-randomized clinical trial. J Cardiothorac Surg. 2020 Sep 29;15(1):283. doi: 10.1186/s13019-020-01340-7.
PubMed 32993716
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-selective Assessment of Carotid Artery Stenosis and Lower Limb Peripheral Ischemia Prior to Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT03516929
- Acronym / sponsor ID
- FMASU R 25/2018
- Conditions
- Carotid Artery Diseases, Peripheral Artery Disease
- Keywords
- carotid, peripheral arterial disease, endarterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Mr Ihab AliUniversity, hospital or other
- Study start
- 5 Aug 2018 (actual)
- Primary completion
- 25 Apr 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 7 May 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.
From our experience among Egyptian population in our institution, there is an increased prevalence of hidden subclinical peripheral artery disease along with carotid artery affection. Thus, increasing the risk of post-operative morbid complications.We aim to evaluate routine/ non-selective carotid and peripheral arterial screening in asymptomatic patients undergoing coronary artery bypass grafting in the Egyptian populationIt is a prospective, non-randomized, comparative study including two groups of patients. The study will start from the day of approval of the ethical committee. It will include 260 patients, on basis of "all new comers". Patients will be examined and classified as "high-risk" group (ɳ = 130) or "low-risk" group (ɳ=130).
All patients will have the "routine" preoperative investigations along with evaluation of extracranial carotid system by non-invasive carotid duplex and lower limb arterial system by non-invasive bilateral lower limb arterial duplex.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high risk group | Active comparator | Diagnostic Test: carotid duplex, both LL arterial duplexhistory of stroke or TIA, carotid bruit, left main stem disease, other peripheral vascular disease |
| low risk group | Sham comparator | Diagnostic Test: carotid duplex, both LL arterial duplexNo history or stroke,TIA. NO left main stem disease |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- The acceptance of the patients to participate in the study in the form of a written consent.
- Patients of both sexes.
- Three vessels disease for CABG.
- Patients' age: from 35 to 75 years old.
- Elective, isolated, primary cases of CABG.
Key exclusion criteria (9 listed)
- Patients refusing to participate in the study.
- Age 76 years or above
- Morbid obese patients (body mass index more than 35).
- Patients who underwent coronary stenting before.
- Patients who underwent previous cardiac operation before.
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 |
|---|---|---|
| carotid duplex, both LL arterial duplexassessment of carotid stenosis and lower limb peripheral ischemia. | Diagnostic test | high risk group, low risk group |
Primary outcome
culprit pathology in carotid and / or lower limb duplex
Time frame: 6 months
1 secondary outcome
new cerebrovascular event or lower limb ischemia in the post operative period
Time frame: 6 months
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 26 May 2020.
- Derived from this study: PubMed 32993716Ali I, Shokri H, Abd Al Jawad M. Assessment of carotid artery stenosis and lower limb peripheral ischemia before coronary artery bypass grafting operations: a non-randomized clinical trial. J Cardiothorac Surg. 2020 Sep 29;15(1):283. doi: 10.1186/s13019-020-01340-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing carotid duplex, both LL arterial duplex in people with Carotid Artery Diseases and Peripheral Artery Disease, run by Mr Ihab Ali 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 11 inclusion and 9 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 26 May 2020. 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. Some participants in this study may receive a placebo. 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?
culprit pathology in carotid and / or lower limb duplex (time frame: 6 months). 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 NCT03516929, which also lists 1 linked publication.
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 26 May 2020.