The REFLO-STEMI trial comparing intracoronary adenosine, sodium nitroprusside and standard therapy for the attenuation of infarct size and microvascular obstruction during primary percutaneous coronary intervention: study protocol for a randomised controlled trial

Table 2 Study outcome measures

Type of outcome measure	Outcome measures
CMRI parameters	● IS (% total LV mass): Primary outcome
	● Incidence and extent of MVO (% LV mass)
	● Myocardial salvage index (MSI)
	● Intra-myocardial haemorrhage (IMH)
	● LV ejection fraction (LVEF) and volumes
Angiographic markers of MVO	● TIMI flow grade [87]
	● Corrected TIMI frame count (cTFC) [85, 86]
	● TIMI myocardial perfusion grade (TMPG) [82, 83, 88]
	● Computer-assisted myocardial blush quantification using the software ‘Quantitative Blush Evaluator’ (QuBE) [84]
	● Incidence pre- and post-procedure of angiographic true ‘no-reflow’
	● Incidence of angiographic slow/no-reflow after P-PCI
ECG	● Degree of ST segment resolution on ECG [16, 81]
Echocardiography	● LV function at baseline and 3 months
Sub-analyses	● Comparing CMRI markers with other myocardial perfusion markers (angiographic, ECG and cardiac enzymes)
Sub-analyses	● Overall MACE and its components at 1 month: death, need for TLR, recurrent MI, severe heart failure and CVE

CMRI, cardiac magnetic resonance imaging; CVE, cerebrovascular event; ECG, electrocardiogram; e-GFR, estimated glomerular filtration rate; LV, left ventricular; LVEF, MACE, major adverse cardiac events; MI, myocardial infarction; MVO, microvascular obstruction; P-PCI, primary percutaneous coronary intervention; SBP, systolic blood pressure; TIMI, Thrombolysis in Myocardial Infarction; TLR, target lesion revascularisation.

ISSN: 1745-6215