Clinical trial NCT03625089: Impact of Nurse-led Programme With Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis
Official title: The Impact of Nurse-led Programme With and Without Carotid Ultrasound on Addressing Cardiovascular Risk in Patients With Arthritis: a Prospective, Multicentre, Randomised, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Arthritis, Rheumatoid
Arthritis, Psoriatic
Keywords: Carotid Atherosclerosis
Arterial Stiffness
Cardiovascular Risk
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Elevated CVD risk is a significant public health problem that contributes greatly to the increased morbidity and shortened lifespan of individuals with RA and PsA. Over the past decades, there has been great progress into the understanding of the severity of CVD risk in these patients but these risk factors are not well managed. The development of the high-risk strategy is therefore necessary, with more intensive therapy reserved for patients identified as high-risk, e.g. because they have high-risk FRS. However, these risk scores under-estimated CV risk in patients with RA and PsA. An intermediate approach is to use quantification of preclinical vascular disease to further identify high-risk patients. Results from this study will provide clinical implications in terms of detecting and managing cardiovascular morbidity in patients with RA and PsA.

Detailed description: Objectives This study investigates the impact of a nurse-led programme on cardiovascular (CV) risk screening with and without carotid ultrasound for carotid plaque on CV risk factor control in asymptomatic rheumatoid arthritis (RA) and psoriatic arthritis (PsA) patients.

Hypothesis The investigators hypothesize that CV risk stratification and management in RA and PsA may be improved by incorporation of carotid ultrasound to assess for carotid plaque.

Eligibility criteria: Inclusion Criteria:

* Patients with RA fulfilled the 2010 ACR/EULAR classification criteria or PsA fulfilled the Classification of Psoriatic Arthritis (CASPAR) criteria
* aged between 18 and 75 will be recruited.

Exclusion Criteria:

* had a history of overt CVD (ie, symptomatic coronary artery disease \[CAD\] or ischemic stroke or transient ischemic attack or peripheral vascular disease)
* had significant co-morbidities including severe renal impairment or severe deranged liver function
* female of childbearing potential who are unwilling to use adequate contraception, pregnant or breastfeeding women
* patients who are already taking lipid lowering therapy.

Primary outcomes:
measure: change in Framingham risk score
timeFrame: 12 months
Secondary outcomes:
measure: Change in pulse wave velocity (PWV) in subjects
timeFrame: 12 months
measure: Change in augmentation index (AIX) in subjects
timeFrame: 12 months
measure: Change in individual modifiable risk factors levels
timeFrame: 12 months
measure: The number of measures taken against comorbidities
timeFrame: 12 months
measure: Proportions of patients achieving remission
timeFrame: 12 months
measure: Changes in intima-media thickness (IMT)
timeFrame: 12 months
measure: Proportion of plaque progression
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Medicine and Therapeutics
Study officials:
affiliation: Chinese University of Hong Kong
name: Lai Shan Tam, MD
role: PRINCIPAL_INVESTIGATOR
References: