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Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

Primary Purpose

Carotid Stenosis

Status

Unknown status

Phase

Not Applicable

Locations

Ireland

Study Type

Interventional

Intervention

Risk Factors Modification Programme

Standard Care

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring Asymptomatic Carotid Artery Stenosis, Cardiovascular risk factors, Risk factor modification

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Vascular Surgery, Western Vascular Institute, Galway University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Risk Factors Modification Programme

Standard Care

Arm Description

Patients in the intervention arm will attend the 12-week intensive lifestyle programme which includes healthy lifestyle change such as smoking cessation, healthy food choices and increasing physical activity levels, as well as management of cholesterol, diabetes, and blood pressure. The 12-week programme will consist of 12 sessions of 2.5 hours each per week. Each of the weekly sessions will incorporate an individualised meeting between the multidisciplinary healthcare team and each patient to review the progress and health goals. The weekly sessions will also include a one-hour group exercise programme and an educational workshop.

Standard care is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.

Outcomes

Primary Outcome Measures

Achieve Lifestyle modification target

This is a composite primary endpoint. The patient will be considered to have achieved the composite primary endpoint if they achieve any one or more of the following targets: Smoking cessation. Body Mass Index (BMI) between 20 to 25 kg/m^2. BMI is calculated by dividing body weight in kilograms by the square of height in metres. Glycosylated Haemoglobin (HbA1C) less than 7%.

Secondary Outcome Measures

Cardiovascular events

Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.

Changes in the degree of carotid artery stenosis

Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.

Carotid artery revascularisation

Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.

Re-intervention rates

Any re-intervention among patients who already underwent carotid revascularisation procedures.

Change in cognitive function

Assessed using the Mini-Mental State Examination (MMSE) at enrolment and after one year. The Mini-Mental State Examination (MMSE) is a validated 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment, patient's orientation, attention, memory, language, and visual-spatial skills. The maximum score is 30 points (out of 30). Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. Moderate to low scores correlate closely with the presence of dementia. A version of the MMSE questionnaire can be found on the British Columbia Ministry of Health website.

Change in quality of life

Assessed using the Dartmouth Cooperative Information Project (COOP) charts at enrolment and after one year. The COOP charts measure six core aspects of functional status: physical fitness, feelings, daily activities, social activities, change in health, pain, and overall health. The instrument consists of six charts, referring to the above mentioned aspects of functioning. Each chart consists of a simple title, a question referring to the status of the patient and an ordinal five-point response scale illustrated with a simple drawing. Each item is rated on this five-point ordinal scale ranging from 1 (no limitation at all) to 5 (severely limited); for 'change in health' score 1 means 'much better' and score 5 'much worse'. The designers do not advocate summing the responses to gain a single index ﬁgure of health status.

Full Information

NCT ID

NCT03929354

First Posted

December 19, 2018

Last Updated

August 3, 2021

Sponsor

Western Vascular Institute, Ireland

1. Study Identification

Unique Protocol Identification Number

NCT03929354

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Western Vascular Institute, Ireland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carotid Stenosis

Keywords

Asymptomatic Carotid Artery Stenosis, Cardiovascular risk factors, Risk factor modification

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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.

Masking

InvestigatorOutcomes Assessor

Masking Description

Blinding of trial participants and care providers is not possible because of obvious differences between the interventions. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.

Allocation

Randomized

Enrollment

208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Risk Factors Modification Programme

Arm Type

Experimental

Arm Description

Arm Title

Standard Care

Arm Type

Active Comparator

Arm Description

Standard care is defined as giving information and advice to the patients to modify their lifestyles but without providing a structured intervention or an individualised plan.

Intervention Type

Behavioral

Intervention Name(s)

Risk Factors Modification Programme

Intervention Description

12-week supervised risk factor modification programme derived from the EuroAction Study standards.

Intervention Type

Behavioral

Intervention Name(s)

Standard Care

Intervention Description

Patients advised to adjust lifestyle without the support of the structured supervised programme.

Primary Outcome Measure Information:

Title

Achieve Lifestyle modification target

Description

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Cardiovascular events

Description

Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.

Time Frame

1 year

Title

Changes in the degree of carotid artery stenosis

Description

Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.

Time Frame

1 year

Title

Carotid artery revascularisation

Description

Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.

Time Frame

1 year

Title

Re-intervention rates

Description

Any re-intervention among patients who already underwent carotid revascularisation procedures.

Time Frame

1 year

Title

Change in cognitive function

Description

Time Frame

1 year

Title

Change in quality of life

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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: Blood pressure > 140/80 mmHg Fasting blood sugar > 53 mmol/mol (HbA1c > 7%) Total cholesterol > 5 mmol/l Low-density lipoprotein (LDL) cholesterol > 2.6 mmol/l Triglycerides > 1.7 mmol/l High-density lipoprotein (HDL) cholesterol ˂ 1.2 mmol/l in females, and ˂ 1 mmol/l in males. Body mass index (BMI) > 25 kg/m^2. Waist circumference of > 80 cm in women, and > 94 cm in men. Mediterranean diet score < 12 Physically inactive. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wael Tawfick, MB BcH,MRCSI

Phone

+ 35391542535

wael.tawfick@hse.ie

First Name & Middle Initial & Last Name or Official Title & Degree

Sherif Sultan, MD, FRCSI

Phone

+35391542534

sherif.sultan@hse.ie

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wael Tawfick, MB BcH,MRCSI

Organizational Affiliation

Western Vascular Institute, Ireland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sherif Sultan, MD, FRCSI

Organizational Affiliation

Western Vascular Institute, Ireland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Abdelsalam BenSaaud, MB BcH, MSc

Organizational Affiliation

Western Vascular Institute, Ireland

Official's Role

Study Director

Facility Information:

Facility Name

Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

City

Galway

Country

Ireland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sherif Sultan, MD

Phone

+35391542534

sherif.sultan@hse.ie

First Name & Middle Initial & Last Name & Degree

Wael Tawfick, MD

Phone

+35391542535

wael.tawfick@hse.ie

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data (IPD) of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality

Citations:

PubMed Identifier

23612326

Citation

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Citation

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Citation

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Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis

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