to determine if exercise induced ischemia of the hand is present and if exercise induced ischemia of the hand leads to functional problems in patients with RAO
ID
Source
Brief title
Condition
- Coronary artery disorders
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hand ischemia will primarily be evaluated with measurement of thumb capillary
lactate changes after manual stress testing, and secondary, with changes of
thumb transcutaneous partial pressure of oxygen.
Secondary outcome
Functional capacity of the hand will be evaluated by handgrip strength,
sensibility of the hand and the QuickDASH questionnaire. The outcome parameters
will be compared between patients with and without RAO.
Background summary
Despite the benefits of transradial access, complications do occur and became
more apparent when implemented in a real world clinical setting. Radial artery
occlusion (RAO) is the most common complication (5 up to 38%) but rarely leads
to major ischemic events due to the collateral perfusion of the hand. However,
it has been reported that radial artery occlusion can become symptomatic,
possibly as a consequence of hand-ischemia. This may compromise upper limb
function, however, this has not been evaluated in a large group of patients. We
therefore initiated a multicentre observational study to evaluate the clinical
consequences of RAO.
Study objective
to determine if exercise induced ischemia of the hand is present and if
exercise induced ischemia of the hand leads to functional problems in patients
with RAO
Study design
This is a multi center, observational clinical trial. After a transradial
coronary procedure, patients with suspicion of RAO will be asked to
participate. After informed consent signs of hand ischemia will be evaluated
and functional capacity. 6 month follow up will be performed by telephonic
interview; a subpopulation will undergo repeat testing during a follow-up visit
at 6 months.
Study burden and risks
Patients are not at risk during this observational study, all test, except for
thumb lactate measurements (obtained by fingersticks) are non-invasive.
Patients will have some time burden (approximately 180-200 minutes) for
undergoing all tests. There is no direct benefit for the patients, he study is
designed to gain knowledge about the sequel of radial artery occlusion.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
Patients who have undergone a previous TR procedure with a suspected RAO (defined as no radial artery pulse or no flow at ultrasound examination)
Exclusion criteria
1. Unable or not willing to give informed consent
2. Hemodialysis patients with an arteriovenous fistula
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56364.029.16 |