Monitoring according to GCP (Full revasc)

The Department of Medicine at KI needs a study of Full Revasc.

Invitation to tender.

Karolinska Institutet, hereinafter called KI, invites companies, hereinafter called the Tenderers, to submit tenders concerning service for monitoring and all other aspects of the services of a Clinical Research Organization (CRO) and according to GCP.

Signed agreement is to be used by the Department of Medicine (CMM) at KI.

Background.

The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still not well established. Current guidelines recommend PCI of only the infarct related artery (IRA), and that you should consider PCI of other suspected narrowings. A recent retrospective meta-analysis of 34279 patients with 1819 cardiovascular deaths registered during follow-up showed that PCI of the culprit lesion only is associated with reduced mortality.

However, recent small scale randomised controlled trials indicate that in cases where there is anatomically significant non-culprit multi-vessel disease full revascularization of these non-infarct related arteries during the index procedure is superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in stable angina. Whether performing full revascularization of physiologically significant non-culprit lesions for patients with STEMI improves outcome compared to an initial conservative approach or compared to angiography-guided PCI is not known.

Visma notice: https://opic.com/id/afrakcjcko