Condition category
Circulatory System
Date applied
10/06/2016
Date assigned
28/06/2016
Last edited
22/06/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Cardiovascular disease (CVD) is a medical term used to describe a disease of the heart or blood vessels. This includes heart attacks (myocardial infarction, or MI) and stroke.In the early stages, however, it causes changes in the function of the blood vessels, particularly the arteries (vessels that transport blood being pumped from the heart to other areas of the body) . Some of these changes in function is due to inflammation (swelling) and, in theory, reducing this inflammation could reduce the risk of an MI or stroke. Animal studies have shown that certain substances (called SIKs) promote inflammation in the arteries. This study is investigating whether this is the same for humans by doing tests in both healthy volunteers and people that have cardiovascular disease (for example, have had a heart attack or have narrowing of the leg arteries). SIK levels will also be compared with the results from different measures of artery function. If SIK levels are found to be high in cases of poor artery function then this might be a potential new treatment target to prevent cardiovascular disease.

Who can participate?
Three different groups of people are participating in this study. People with peripheral vascular disease and about to have an amputation(group 1), people who have had a heart attack (group 2) and healthy volunteers (group 3). All participants are adults aged between 18-70.

What does the study involve?
Participants in group 1 are asked to give blood for analysis and their amputated tissue is also analysed. Participants in group 2 are also asked to give blood samples and undergo tests to see how stiff their arteries are (arterial stiffness measurements) and how well blood vessels relax after being dilated (widened with increased blood flow). Participants in group 3 are also asked to give blood samples, flow-mediated dilatation (blood vessels widened with increased blood flow) and pulse-wave analysis (arterial stiffness analysis). All participants are followed up for signs of inflammation, their blood vessel function and SIK levels.

What are the possible benefits and risks of participating?
The researchers do not expect there to be any direct risks or benefits to the patient in taking part in the study. Routine clinical care will not be affected regardless of participation in the study. For volunteers, there is the small discomfort of having blood samples taken, however steps will be made to make this as easy as possible.

Where is the study run from?
Ninewells Hospital, Dundee (UK)

When is the study starting and how long is it expected to run for?
February 2016 to November 2017

Who is funding the study?
Tenovus (UK)

Who is the main contact?
Dr Faisel Khan
f.khan@dundee.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Faisel Khan

ORCID ID

http://orcid.org/0000-0002-9889-0229

Contact details

Division of Cardiovascular and Diabetes Medicine
Mailbox 1 Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom
01382 383531
f.khan@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2015CV11

Study information

Scientific title

Investigating the role of salt inducible kinases in atherosclerosis: a observational cross-sectional study

Acronym

Study hypothesis

The key hypothesis is that the SIK-CRTC3 signalling axis will play an important role in development of atherosclerosis. The researchers hypothesise that mechanisms to activate the cAMP response element binding protein (CREB) should protect against cardiovascular disease (CVD), and that inhibition of salt inducible kinase 2 (SIK2) will have beneficial effects on the cardiovascular (CV) system and thus offer a new target for therapy.

Ethics approval

East of Scotland Research Ethics Committee 2.

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

STEMI, peripheral arterial disease

Intervention

3 groups will be evaluated in this study:

Group 1. 10 patients with peripheral vascular disease (PVD) undergoing elective amputation. These patients will undergo blood sampling and amputated tissue analysis.

Group 2. 40 patients with acute myocardial infarction with ST elevation (STEMI) and requiring primary percutaneous coronary intervention (PPCI). These patients will undergo blood samples, flow mediated dilatation (FMD) and arterial stiffness measurements.

Group 3. 40 healthy subjects, matched to the STEMI group for age and gender. They will undergo blood samples, flow-mediated dilatation and pulse wave analysis.

Intervention type

Not Specified

Phase

Drug names

Primary outcome measures

Serum levels of inflammatory cytokines taken at the time of operation in PVD group, 48-72 hours after PCI in STEMI group and at the time of assessment in healthy volunteers.

Secondary outcome measures

1. Tissue SIK levels in PVD patients at the time of surgery
2. Arterial stiffness and flow mediated dilatation in STEMI patients at 48-72 hours and in healthy volunteers at the time of assessment

Overall trial start date

01/02/2016

Overall trial end date

03/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

PVD:
1. Age between 18-70 years
2. Admitted for elective amputation for PVD
3. Able to give written informed consent

STEMI:
4. Age between 18-70 years
5. Admitted to CCU for STEMI and undergone PPCI
6. Able to give written informed consent

Healthy Volunteers:
7. Age between 18-70 years
8. No current or previous significant medical illness
9. Able to give written informed consent

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

Healthy Volunteers:
1.Positive medical history of:
1.1. Vascular diseases such as peripheral arterial disease, stroke, IHD... etc. ,
1.2. Haematological conditions such as hypercoagulability, deep venous thrombosis... etc. ,
1.3. Hypertension.
2. Alcohol excess
3. Unable to give written informed consent

STEMI/PVD:
Unable to give written informed consent

Recruitment start date

01/08/2016

Recruitment end date

01/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor information

Organisation

NHS Tayside/University of Dundee

Sponsor details

c/o Mrs Natalie Smith
Tayside Medical Sciences Centre
3 George Pirie Way
Ninewells Hospital
Dundee
DD1 9SY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Tenovus

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We intend to publish the results at the end of the study in peer-reviewed journals although details are not confirmed as yet.

Intention to publish date

03/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes