Ischemia (FFR) Driven Complete Revascularization versus Usual Care in Patients with Non-ST Elevation Myocardial Infarction and Multivessel Diseases. The South Limburg Myocardial Infarction Study Group

Conditions: coronary artery disease
NSTEMI
non ST-elevation myocardial infarction
multivessel disease
fractional flow reserve
FFR
culprit lesion
coronairlijden
non ST-elevatie myocardinfarct
meervatslijden

Registration Number: NL-OMON23247

Lead Sponsor: Zuyderland Medical Centre, Heerlen, The NetherlandsandMaastricht University Medical Centre +, Maastricht, The Netherlands

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 414

Inclusion Criteria

•Patients aged between 18-85 years presenting with non-STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of >50% in a non-IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator.

•Non-IRA stenosis amenable for PCI treatment (operator’s decision)

Exclusion Criteria

1.Left main disease (stenosis > 50%)

2.Chronic total occlusion of a non-IRA

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary study endpoints are defined as the incidence of MACE (Composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke) at 12 months.

Secondary Outcome Measures

Name	Time	Method
•Primary endpoint in subgroups at 12 and 24 months in the subgroup of patients. <br /><br>•Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months.<br /><br>•Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.<br /><br>•All-cause mortality or Myocardial infarction at 12, 24 and 36 months.. <br /><br>•Any revascularisation at 12, 24 and 36 months.<br /><br>•Stent thrombosis at 12, 24 and 36 months.<br /><br>•Bleeding (major and minor) at 48 hr and 12 months<br /><br>•Primary endpoint at 36 months as well as outcomes of each component of the primary endpoint at 12 and 24 and 36 months.<br /><br>•Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography)<br>