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Study protocol
Marah Elfghi
Galway University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1383-5683
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Background Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as patients with a history of coronary or cerebrovascular disease. Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease.
Atherosclerotic risk factor identification and modification play an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. In this study we aim to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors
Methods This is a randomised, parallel group, active-control trial to compare the effectiveness of the risk factor modification intervention programme to standard healthcare in a tertiary vascular care centre, in the reduction of modified risk factors in PAD patients. The primary outcome of this study is to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors at 3 and 12 months. The secondary outcomes are to compare the impact of the programme on clinical outcomes in PAD patients at 12 months. Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events.
Discussion This study will provide clear evidence on the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors, through a high quality, well-powered clinical trial.
Trial registration This trial was registered (11/07/2017) on the European Clinical Trials Database (EudraCT number 2017-002964-41) and ClinicalTrials.gov (NCT03935776) which was registered on 02 May 2019.
Keywords
Peripheral arterial disease, PAD, atherosclerosis, risk factors, lifestyle and risk factor modification intervention programme, Randomised controlled trial
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CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 11 Jan, 2021
No community comments so far
Editorial decision: Accept
On 31 Jan, 2021
Review #1 received
Received 03 Jan, 2021
Reviewer #1 agreed
On 24 Dec, 2020
Reviewers invited
Invitations sent on 21 Dec, 2020
Editor assigned
On 20 Dec, 2020
Submission checks complete
On 20 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 28 Nov, 2020
Review #2 received
Received 22 Nov, 2020
Review #3 received
Received 22 Nov, 2020
Reviewer #3 agreed
On 18 Nov, 2020
Reviewer #2 agreed
On 15 Nov, 2020
Reviewers invited
Invitations sent on 15 Nov, 2020
Reviewer #1 agreed
On 15 Nov, 2020
Review #1 received
Received 15 Nov, 2020
Editor assigned
On 31 Oct, 2020
Submission checks complete
On 31 Oct, 2020
No comments provided
Review #3 received
Received 20 Aug, 2020
Editorial decision: Major revision
On 20 Aug, 2020
Review #2 received
Received 14 Aug, 2020
Reviewer #3 agreed
On 05 Aug, 2020
Reviewer #2 agreed
On 03 Aug, 2020
Reviewer #1 agreed
On 26 May, 2020
Review #1 received
Received 26 May, 2020
Reviewers invited
Invitations sent on 25 May, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 18 Dec, 2019
First submitted
On 01 Dec, 2019
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A new preprint design is coming!
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See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Marah Elfghi
Galway University Hospital
Corresponding Author
ORCiD: https://orcid.org/0000-0003-1383-5683
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
Version 3
Posted 11 Jan, 2021
No community comments so far
Editorial decision: Accept
On 31 Jan, 2021
Review #1 received
Received 03 Jan, 2021
Reviewer #1 agreed
On 24 Dec, 2020
Reviewers invited
Invitations sent on 21 Dec, 2020
Editor assigned
On 20 Dec, 2020
Submission checks complete
On 20 Dec, 2020
No comments provided
Editorial decision: Minor revision
On 28 Nov, 2020
Review #2 received
Received 22 Nov, 2020
Review #3 received
Received 22 Nov, 2020
Reviewer #3 agreed
On 18 Nov, 2020
Reviewer #2 agreed
On 15 Nov, 2020
Reviewers invited
Invitations sent on 15 Nov, 2020
Reviewer #1 agreed
On 15 Nov, 2020
Review #1 received
Received 15 Nov, 2020
Editor assigned
On 31 Oct, 2020
Submission checks complete
On 31 Oct, 2020
No comments provided
Review #3 received
Received 20 Aug, 2020
Editorial decision: Major revision
On 20 Aug, 2020
Review #2 received
Received 14 Aug, 2020
Reviewer #3 agreed
On 05 Aug, 2020
Reviewer #2 agreed
On 03 Aug, 2020
Reviewer #1 agreed
On 26 May, 2020
Review #1 received
Received 26 May, 2020
Reviewers invited
Invitations sent on 25 May, 2020
Editor assigned
On 30 Dec, 2019
Submission checks complete
On 18 Dec, 2019
First submitted
On 01 Dec, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background Peripheral arterial disease (PAD) affects more than 200 million of the global population. PAD represents a marker for premature cardiovascular events. Patients with PAD, even in the absence of a history of myocardial infarction or ischemic stroke, have approximately the same relative risk of death from cardiovascular causes as patients with a history of coronary or cerebrovascular disease. Despite the high prevalence of PAD and the strong association with cardiovascular morbidity and mortality, patients with PAD are less likely to receive appropriate treatment for their atherosclerotic risk factors than those who are being treated for coronary artery disease.
Atherosclerotic risk factor identification and modification play an important role in reducing the number of adverse outcomes among patients with atherosclerosis. Risk reduction therapy decreases the risk of cardiovascular mortality and morbidity in patients with PAD. In this study we aim to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors
Methods This is a randomised, parallel group, active-control trial to compare the effectiveness of the risk factor modification intervention programme to standard healthcare in a tertiary vascular care centre, in the reduction of modified risk factors in PAD patients. The primary outcome of this study is to evaluate the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors at 3 and 12 months. The secondary outcomes are to compare the impact of the programme on clinical outcomes in PAD patients at 12 months. Secondary outcomes include amputation-free survival, clinical improvement, haemodynamic improvement, need for revascularisation procedures, outcomes of revascularisation procedures, changes in quality of life and the incidence of adverse events.
Discussion This study will provide clear evidence on the effectiveness of a lifestyle and risk factor modification intervention programme in achieving treatment goals for PAD risk factors, through a high quality, well-powered clinical trial.
Trial registration This trial was registered (11/07/2017) on the European Clinical Trials Database (EudraCT number 2017-002964-41) and ClinicalTrials.gov (NCT03935776) which was registered on 02 May 2019.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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