Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04825080 |
| Other study ID # |
STECA |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2019 |
| Est. completion date |
January 1, 2025 |
Study information
| Verified date |
March 2021 |
| Source |
University of Bologna |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
There is debate on the natural history of asymptomatic severe carotid artery stenosis.
Previous studies conducted more than 20 years ago revealed the benefit of carotid
endarterectomy compared with medical therapy only on the stroke prevention. However, today it
seems that the current medical regimen can reduce the cerebral ischemic event rate in
patients with asymptomatic severe carotid artery stenosis to less than 1% per year, making it
questionable to choose the surgical treatment.
Description:
The Primary end point is to evaluate the rate of cerebral ischemic events (stroke or
transient ischemic attack) in patients with asymptomatic carotid artery stenosis > 60%
(Nascet criteria) in a 5-year follow-up period. It is a prospective observational study
conducted on patients enrolled from January 2019 to March 2020 and with the end of follow-up
scheduled in 2025.
The medical therapy recommended includes antihypertensive drugs to maintain good blood
pressure control, statin therapy and antiplatelet administration.
Secondary end points are the evaluation of plaque progression, the identification of
comorbidities or plaque characteristics associated with a higher risk for cerebral ischemic
events and the patient adherence to the best medical therapy in a real world scenario. The
global survival and the factors influencing survival will be investigated as well.
Separate analyses are performed for patients with total carotid occlusion or carotid artery
re-stenosis.
Patient's cohort: with the hypothesis of 3 neurologic (transient ischemic attack or stroke)
events per 100 patients/year during a 5 years follow-up period and consequently a number of
40-50 events (primary outcome), the study cohort with a native asymptomatic carotid artery
stenosis will include at least 300 patients. Patients with carotid occlusion or restenosis
are evaluated separately for a secondary analysis only.
Patients are prospectively identified and enrolled in a single center vascular surgery
ambulatory and a duplex ultrasonography (DUS) laboratory. Carotid artery stenosis are
identified and the degree of stenosis >60% (NASCET criteria) is evaluated according to the
current guidelines for stenosis identification through blood flow velocities. Patients
enrollment goes from January 2019 to March 2020. The investigators prospectively complete the
dedicated database including clinical characteristics, cardiovascular risk factors, medical
therapy in use, features of the carotid plaque and contralateral carotid status.
Clinical characteristics included in the database: age, sex, hypertension (systolic blood
pressure ≥140 or/and diastolic ≥90 mmHg, or specific therapy), dyslipidemia (total
cholesterol ≥200 mg/dl or low density lipoprotein ≥120 mg/dl or specific therapy), diabetes
mellitus (pre-diagnosed, in therapy with oral hypoglycemic drugs or insulin), current
smoking, coronary artery disease (defined as a history of angina pectoris, myocardial
infarction or coronary revascularization), chronic obstructive pulmonary disease (defined as
chronic bronchitis or emphysema), chronic kidney disease (glomerular filtration rate <60
ml/min), contralateral carotid occlusion, stenosis and atrial fibrillation (paroxysmal or
permanent).
Medical therapy: antiplatelet types, anticoagulant therapy, statin therapy, anti hypertensive
medical therapy.
Carotid plaque characteristics for the analysis: degree of stenosis (flow measurement
analysis), plaque ulcerations and echoluncency.
The follow-up consists of a telephone interview any six months and an annual clinical and
duplex examination until a 5-years follow-up is reached or the patient withdraws from the
study.
Patients that will be enrolled will sign specific consents. Sensitive patient information
will not be available during data analysis. The clinical study will be carried out according
to the ethical principles of the Declaration of Helsinki and following the active regulations
on observational studies.
Patients who underwent a transient ischemic attach or a stroke within the 6-months before the
enrollment are excluded from the study. Any neurological symptom occurred during the
follow-up needs to be certified by an in hospital neurologist physical examination.
Statistical analysis: Continuous variables were described with mean and standard deviation.
Continuous variables were compared by unpaired Student' t test in case of normal
distribution, otherwise by Mann-Whitney's test. The differences between percentages were
assessed using Fisher's test or Chi-square test, when appropriate. Univariate analysis will
be performed by Kaplan Meier analysis (log-rank test) and single factor Cox analysis .
Multivariate analyses with Cox analysis will be performed including factors considered
statistical significant (P value ≤ .05) at the univariate analyses. Risk factors were
reported as hazard ratio (HR) and 95% of confidence interval (CI). A value of p ≤ .05
(two-tailed) was considered to be significant. The statistical tests were performed using
SPSS® 21.0 for Windows® (SPSS, Chicago, Il, USA).
