Lifestyle Modification Programme for Patients With Asymptomatic Carotid Artery Stenosis
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|ClinicalTrials.gov Identifier: NCT03929354|
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Carotid Stenosis||Behavioral: Risk Factors Modification Programme Behavioral: Standard Care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Investigator, Outcomes 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.|
|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|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Experimental: Risk Factors Modification Programme
Behavioral: Risk Factors Modification Programme
12-week supervised risk factor modification programme derived from the EuroAction Study standards.
Active Comparator: Standard Care
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.
Behavioral: Standard Care
Patients advised to adjust lifestyle without the support of the structured supervised programme.
- Achieve Lifestyle modification target [ Time Frame: 12 weeks ]
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%.
- Cardiovascular events [ Time Frame: 1 year ]Any of cerebrovascular events (Transient ischaemic attack or stroke), myocardial infarction, or death.
- Changes in the degree of carotid artery stenosis [ Time Frame: 1 year ]Any increase or decrease in the percentage of internal carotid artery stenosis, documented by duplex scan.
- Carotid artery revascularisation [ Time Frame: 1 year ]Any need for carotid endarterectomy or carotid stenting, with any documented procedure complications.
- Re-intervention rates [ Time Frame: 1 year ]Any re-intervention among patients who already underwent carotid revascularisation procedures.
- Change in cognitive function [ Time Frame: 1 year ]
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 [ Time Frame: 1 year ]
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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929354
|Contact: Wael Tawfick, MB BcH,MRCSI||+ firstname.lastname@example.org|
|Contact: Sherif Sultan, MD, FRCSIemail@example.com|
|Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital||Recruiting|
|Contact: Sherif Sultan, MD +35391542534 firstname.lastname@example.org|
|Contact: Wael Tawfick, MD +35391542535 email@example.com|
|Principal Investigator:||Wael Tawfick, MB BcH,MRCSI||Western Vascular Institute, Ireland|
|Principal Investigator:||Sherif Sultan, MD, FRCSI||Western Vascular Institute, Ireland|
|Study Director:||Abdelsalam BenSaaud, MB BcH, MSc||Western Vascular Institute, Ireland|