Clinical trial NCT03929354: Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis
Official title: Intensive Lifestyle Modification Programme Versus Standard Care for Risk Factor Reduction and Stroke Prevention in Patients With Asymptomatic Carotid Artery Stenosis. A Prospective Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Stenosis
Keywords: Asymptomatic Carotid Artery Stenosis
Cardiovascular risk factors
Risk factor modification
Lead sponsor: Western Vascular Institute, Ireland
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.
Primary purpose: TREATMENT

Brief summary: This study randomises patients with patients with asymptomatic carotid artery stenosis, to be managed either by providing an intensive 12-week lifestyle modification programme, or standard healthcare.

Detailed description: Cardiovascular disease (CVD) is the leading cause of mortality and acquired disability globally. According to the World Health Organisation (WHO), 30% of total global deaths are due to CVD, and approximately 6 million deaths result from cerebrovascular disease.

A common cause of cerebrovascular disease is internal carotid artery stenosis. Despite recent advances in carotid artery revascularisation, risk factor modification remains the cornerstone of therapy for this devastating disease. According to the European Society of Cardiology (ESC), the lifestyle risk factors for vascular diseases include; cigarette smoking, physical inactivity, increased body mass index, and unhealthy diet, and stress, while the medical risk factors include; High blood pressure, elevated blood sugar, and hyperlipidaemia. All these factors have been identified in several studies as significant modifiable risk factors that should be targeted for preventing morbidity and mortality resulting from cerebrovascular disease.

Previous studies indicated that modifiable risk factor programmes can help cardiac patients to achieve their risk factor modification targets. However, to date there do not seem to be any studies assessing the outcomes of a multidisciplinary risk factor modification programme in patients with carotid artery stenosis. Our study will evaluate the impact of an intensive 12-week, multidisciplinary risk factors modification programme on medical and lifestyle risk factors modification, as well as on risk reduction for stroke and cardiovascular events, among patients with asymptomatic carotid artery stenosis. We will compare these outcomes to that of standard care traditionally provided to this high-risk patient group.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or more.
* Provide written informed consent.
* History of asymptomatic carotid artery stenosis, defined as a stenosis of the internal carotid artery of 50% or higher, but without history of any cerebrovascular events within the previous 6 months.
* Patients should have at least one of the following risk factors:

  1. Blood pressure \> 140/80 mmHg
  2. Fasting blood sugar \> 53 mmol/mol (HbA1c \> 7%)
  3. Total cholesterol \> 5 mmol/l
  4. Low-density lipoprotein (LDL) cholesterol \> 2.6 mmol/l
  5. Triglycerides \> 1.7 mmol/l
  6. High-density lipoprotein (HDL) cholesterol ˂ 1.2 mmol/l in females, and ˂ 1 mmol/l in males.
  7. Body mass index (BMI) \> 25 kg/m\^2.
  8. Waist circumference of \> 80 cm in women, and \> 94 cm in men.
  9. Mediterranean diet score \< 12
  10. Physically inactive.
  11. Current smoker or exposure to tobacco in any form.

Exclusion Criteria:

* Patients with symptomatic carotid stenosis and with a documented symptomatic cerebrovascular event. A cerebrovascular event is considered if the patient experienced any of an amaurosis fugax, transient ischaemic attack (TIA), or stroke within the past 6 months.
* Significant cognitive impairment or mental illness.
* Currently pregnant women (confirmed by β-Human chorionic gonadotropin (HCG) analysis).
* Inadequate English language ability to understand the content of the intervention programme.
* Involvement in another clinical trial in the previous six months.
* Legal incapacity.
* Patient is bed-ridden or immobile.
* Contraindication to antiplatelet or anticoagulation therapy, or any of risk factor medications.
* Presence of any illness that could limit long-term compliance.

Primary outcomes:
measure: Achieve Lifestyle modification target
timeFrame: 12 weeks
Secondary outcomes:
measure: Cardiovascular events
timeFrame: 1 year
measure: Changes in the degree of carotid artery stenosis
timeFrame: 1 year
measure: Carotid artery revascularisation
timeFrame: 1 year
measure: Re-intervention rates
timeFrame: 1 year
measure: Change in cognitive function
timeFrame: 1 year
measure: Change in quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital
Study officials:
affiliation: Western Vascular Institute, Ireland
name: Wael Tawfick, MB BcH,MRCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Vascular Institute, Ireland
name: Sherif Sultan, MD, FRCSI
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Vascular Institute, Ireland
name: Abdelsalam BenSaaud, MB BcH, MSc
role: STUDY_DIRECTOR
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