Carotid StenosisPhase 3CACEANCT02260453
Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
A Phase 3 study testing Preoperative coronary angiography and Standard cardiac workup in people with Carotid Stenosis and Coronary Stenosis, run by University of Roma La Sapienza.
Trial summary
The purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Stenosis, Coronary Stenosis
- What is being tested?
- Preoperative coronary angiography and Standard cardiac workup
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jun 2012
- Phase
- Phase 3
- 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
Who may be able to join
- indication for carotid endarterectomy
- no clinical sign or history of ischemic heart disease
- no electrical signs of cardiac ischemia
- left ventricular ejection fraction >50% at transthoracic echocardiogram.
Who cannot join
- disabling stroke (mRS ≥3)
- non atherosclerotic carotid disease
- severe intracranial carotid artery stenosis
- contra-indications to heparin, aspirin or clopidogrel.
About this study
Official title: Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
The purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy (CEA).
Read the detailed description
Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n = 210) CEA was performed without coronary angiography.
- Conditions
- Carotid Stenosis, Coronary Stenosis
- Being tested
- Preoperative coronary angiography, Standard cardiac workup
- Medical subject headings
- Carotid Stenosis, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative coronary angiographyOther
If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
Standard cardiac workupOther
EKG, transthoracic cardiac echocardiogram
| Study group | Role | What they receive |
|---|---|---|
| A - Coronary angiography | Active comparator | All the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG) Receives: Other: Preoperative coronary angiography |
| B - standard cardiac workup | Active comparator | Standard cardiac workup Receives: Other: Standard cardiac workup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-fatal and fatal myocardial infarction
Measured: 30 days through year 3
Secondary outcomes (1)
All-cause and cardiovascular mortality
Measured: 30 days through year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startJan 2005
- Primary completionJul 2009
- Study completionJun 2012
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 StenosisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giulio Illuminati, University of Roma La Sapienza
- Investigators
- Giulio Illuminati, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260453
- Sponsor's protocol ID
- University "La Sapienza" Rome
- Acronym
- CACEA
- Status last verified
- Oct 2014
- First submitted
- 6 Oct 2014
- Last updated
- 9 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Illuminati G, Schneider F, Greco C, Mangieri E, Schiariti M, Tanzilli G, Barilla F, Paravati V, Pizzardi G, Calio' F, Miraldi F, Macrina F, Totaro M, Greco E, Mazzesi G, Tritapepe L, Toscano M, Vietri F, Meyer N, Ricco JB. Long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease. Eur J Vasc Endovasc Surg. 2015 Apr;49(4):366-74. doi: 10.1016/j.ejvs.2014.12.030. Epub 2015 Feb 18.
PubMed 25701070
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Analyzing the Role of Systematic Preoperative Coronary Angiography Before Elective Carotid Endarterectomy in Patients With Asymptomatic Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02260453
- Acronym / sponsor ID
- CACEA / University "La Sapienza" Rome
- Conditions
- Carotid Stenosis, Coronary Stenosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Oct 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 purpose of this study is to evaluate the potential benefit of systematic preoperative coronary angiography followed by selective coronary artery revascularization on the incidence of myocardial infarction (MI) in patients without a history of coronary artery disease (CAD) and undergoing carotid endarterectomy (CEA).
Detailed description
Patients candidates for CEA, with no history of CAD, a normal electrocardiogram (ECG), and a normal cardiac ultrasound were randomized in two groups. In group A (n = 216) all patients underwent coronary angiography before CEA +- coronary artery revascularization. In group B (n = 210) CEA was performed without coronary angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A - Coronary angiography | Active comparator | Other: Preoperative coronary angiographyAll the patients receive preoperative coronary angiography followed, if needed, by percutaneous intervention (PCI) or bypass (CABG) |
| B - standard cardiac workup | Active comparator | Other: Standard cardiac workupStandard cardiac workup |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- indication for carotid endarterectomy
- no clinical sign or history of ischemic heart disease
- no electrical signs of cardiac ischemia
- left ventricular ejection fraction >50% at transthoracic echocardiogram.
Key exclusion criteria (4 listed)
- disabling stroke (mRS ≥3)
- non atherosclerotic carotid disease
- severe intracranial carotid artery stenosis
- contra-indications to heparin, aspirin or clopidogrel.
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 |
|---|---|---|
| Preoperative coronary angiographyIf coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied | Other | A - Coronary angiography |
| Standard cardiac workupEKG, transthoracic cardiac echocardiogram | Other | B - standard cardiac workup |
Primary outcome
Non-fatal and fatal myocardial infarction
Time frame: 30 days through year 3
1 secondary outcome
All-cause and cardiovascular mortality
Time frame: 30 days through year 3
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 9 Oct 2014.
- Derived from this study: PubMed 25701070Illuminati G, Schneider F, Greco C, Mangieri E, Schiariti M, Tanzilli G, Barilla F, Paravati V, Pizzardi G, Calio' F, Miraldi F, Macrina F, Totaro M, Greco E, Mazzesi G, Tritapepe L, Toscano M, Vietri F, Meyer N, Ricco JB. Long-term results of a randomized controlled trial analyzing the role of systematic pre-operative coronary angiography before elective carotid endarterectomy in patients with asymptomatic coronary artery disease. Eur J Vasc Endovasc Surg. 2015 Apr;49(4):366-74. doi: 10.1016/j.ejvs.2014.12.030. Epub 2015 Feb 18.
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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.
Giulio Illuminati, MD principal investigator
University of Roma La Sapienza
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preoperative coronary angiography and Standard cardiac workup in people with Carotid Stenosis and Coronary Stenosis, run by University of Roma La Sapienza.
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 4 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 9 Oct 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
What does the primary outcome measure?
Non-fatal and fatal myocardial infarction (time frame: 30 days through year 3). 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 NCT02260453, 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 9 Oct 2014.