Vascular Diseases Clinical Trial
Official title:
Prognostic Markers of Outcome in Patients Undergoing Infra-inguinal Revascularisation. A Prospective Observational Study.
Over 3000 people each year undergo bypass operations to their lower limbs, and these
operations carry significant risks with approximately 1 in 20 of these people dying in
hospital, and another 1 in 20 having a heart attack.
Assessment of these patients in order to stratify their risk of both dying and having
significant complications aid in improving their care, enable better utilisation of scarce
critical care resources, and allow us to give patients better information on which to base
consent.
Aims The aims of the project are to assess the feasibility of exercise testing this group of
patients both with cycle and arm exercise, and to identify markers of outcome in this group.
Methodology This is a prospective observational study designed to test the hypothesis that a
combination of cardiopulmonary exercise testing and blood tests provides prognostic value on
outcome measures after surgery for lower limb revascularisation
Subjects will have 2 exercise tests, one arm and one cycle, prior to surgery at their
preoperative assessment appointment. From these tests we will measure how much work patients
can do, how much oxygen they are able to use, and when the heart is unable to deliver enough
oxygen to the cells. In addition they will have blood samples taken prior to the operation
(brain natriuretic peptide), and on days 1 and 3 (troponin I) after the operation to look at
cardiac markers of damage.
This data will be used to see if we can predict those patients that have both short and long
term complications, and also to see whether the different forms of exercise testing are
comparable, or if one type is superior.
Expected outcomes We expect that through a combination of exercise testing and blood test we
will be able to identify patients at increased risk of complications after surgery. We also
expect to find that arm exercise will be a more feasible and informative test that cycle
exercise.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - All patients undergoing elective and expedited infra inguinal peripheral revascularisation. Patients undergoing radiological assessment (angiography) and/or radiological intervention for peripheral vascular disease Exclusion Criteria: - Patients refusing to participate in the study or unable to give informed consent. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | York Teaching Hospitals NHS Foundation Trust | York | North Yorkshire |
Lead Sponsor | Collaborator |
---|---|
York Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year all cause mortality | 1 year | No | |
Secondary | 1 year major adverse cardiac event. | 1 year | No | |
Secondary | Morbidity as measured by the Post operative morbidity survey | 7 days | No | |
Secondary | major adverse cardiac event. | participants will be followed for the duration of hospital stay, an expected median of 10 days | No | |
Secondary | 30 day all cause mortality. | 30 day | No | |
Secondary | Surgical post operative complications | participants will be followed for the duration of hospital stay, an expected median of 10 days | participants will be followed for the duration of hospital stay, an expected median of 10 days | No |
Secondary | Medical post operative complications | participants will be followed for the duration of hospital stay, an expected median of 10 days | participants will be followed for the duration of hospital stay, an expected median of 10 days | No |
Secondary | Quality of life measured at 6 and 12 months postoperatively by the EQ-5D-5L questionnaire. | 0,6 and 12 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05971407 -
The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults
|
N/A | |
Enrolling by invitation |
NCT03683186 -
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
|
Phase 3 | |
Recruiting |
NCT04390672 -
Multivessel TALENT
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Completed |
NCT01915368 -
Determining Optimal Post-Stroke Exercise (DOSE)
|
N/A | |
Completed |
NCT01684826 -
X-ray Dose Reduction Study for Cardiac Angiography and Intervention
|
N/A | |
Terminated |
NCT00935766 -
Effect of Fish Oil (Omega-3 Fatty Acids) on Arteries
|
Phase 3 | |
Unknown status |
NCT01748383 -
The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)
|
Phase 2 | |
Recruiting |
NCT05907564 -
Aventus Thrombectomy System Pulmonary Embolism Clinical Study
|
N/A | |
Recruiting |
NCT03732612 -
Inflammation in Vascular Disease
|
||
Completed |
NCT00000614 -
Prevention of Recurrent Venous Thromboembolism (PREVENT)
|
Phase 3 | |
Completed |
NCT00000479 -
Women's Health Study (WHS): A Randomized Trial of Low-dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
|
Phase 3 | |
Completed |
NCT00000539 -
Arterial Disease Multifactorial Intervention Trial (ADMIT)
|
Phase 3 | |
Completed |
NCT00000530 -
Raynaud's Treatment Study (RTS)
|
Phase 3 | |
Completed |
NCT00000474 -
Prevention and Treatment of Hypertension Study (PATHS)
|
Phase 3 | |
Completed |
NCT00000528 -
Trials of Hypertension Prevention (TOHP)
|
Phase 3 | |
Completed |
NCT00000509 -
Potassium and Sodium to Control Blood Pressure in Hypertensives
|
Phase 3 | |
Completed |
NCT00000501 -
Hypertension Prevention Trial (HPT) Feasibility Study
|
Phase 2 | |
Completed |
NCT00000499 -
Systolic Hypertension in the Elderly Program (SHEP) (Pilot Study)
|
Phase 2 | |
Completed |
NCT04340388 -
Contribution of Dolutegravir to Obesity and Cardiovascular Disease
|
Phase 4 |