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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| University of Oxford | OTHER |
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Arterial occlusion can lead to tissue ischemia and, if prolonged, end organ infarction. Clinical and experimental data would suggest that restoration of blood flow might trigger additional injury beyond that induced by the ischemia alone, so called Ischemia Reperfusion (IR) injury. IR injury impairs endothelial function through a mechanism that may involve intercellular gap junctions. Rotigaptide (ZP-123) is an anti-arrhythmic drug promoting intercellular coupling by increasing gap junction conductance. We intend to test the hypothesis that rotigaptide protects the forearm arterial circulation from IR-induced endothelial dysfunction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Ischaemia reperfusion (IR) injury (upper arm cuff inflated to 200 mmHg for 20 min) is induced during the study. Using bilateral forearm venous occlusion plethysmography, blood flow will be measured during intra-brachial infusion of acetylcholine (ACh; 5-20 µg/min) before and after IR injury and during intra-brachial co-infusion of saline-placebo |
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| 2 | Active Comparator | Ischaemia reperfusion (IR) injury (upper arm cuff inflated to 200 mmHg for 20 min) is induced during the study. Using bilateral forearm venous occlusion plethysmography, blood flow will be measured during intra-brachial infusion of acetylcholine (ACh; 5-20 µg/min) before and after IR injury and during intra-brachial co-infusion of rotigaptide |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forearm vascular study | Procedure | Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in forearm blood flow after ischaemia reperfusion with or without co-infusion of Rotigaptide | 20 fixed timepoints throughout the study up to 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David E Newby, PhD, FRCP | University of Edinburgh | Study Director |
| Rajesh K Kharbanda, PhD, FRCP | University of Oxford | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Edinburgh, 49 Little France Crescent | Edinburgh | EH16 4SB | United Kingdom |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |