Clinical trial NCT04685941: Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia
Official title: Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Microvascular Disease
Myocardial Infarction
Keywords: Coronary Microvascular Disease
Myocardial Infarction
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
Collaborators: name: Barcicore-Lab
First posted: 2020-12-28
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 100 patients with ST-elevation myocardial infarction (STEMI) presenting slow-flow after primary-percutaneous coronary intervention (PPCI) will be randomized to pharmacologic treatment with hyperemic drugs versus flow-mediated hyperemia.

Detailed description: Slow-flow phenomena is observed around 15% of patients undergoing PPCI and has been associated with poor prognosis. Hyperemic drugs, such as nitroprussiate and adenosine, have not yet demonstrated to reduce the infarct size and prognosis in patients with slow flow. Controlled flow-mediated hyperemia using a dedicated catheter for intracoronary saline infusion has been shown to stimulate microcirculatory vasodilatation in stable patients similarly as hyperemic drugs.

The aims of the study are to compare the absolute microcirculatory resistance of the infarct-related artery presenting with slow flow after PPCI, as assessed by intracoronary thermo-dilution, treated with standard pharmacologic hyperemia versus flow-mediated hyperemia; and to compare the angiographic TIMI frame count after treatment of slow flow phenomena with the two investigated strategies.

Eligibility criteria: Inclusion Criteria:

1. ST elevation myocardial infarction Killip I \<12 hours since symptoms onset.
2. ST elevation \> 2 mm anterior leads or \> 1 mm inferior or lateral leads.
3. Sustained slow coronary flow (TIMI flow 0-2) for at least 30 seconds after stent implantation or stent post-dilatation.

Exclusion Criteria:

1. Previous myocardial infarction in the culprit artery
2. Previous stroke
3. Advanced kidney disease (creatinine clearance \<30 ml / min).
4. Active bleeding
5. Allergy to contrast, nitroprussiate or adenosine.
6. Culprit lesion in coronary bypass, left main coronary artery or stent thrombosis
7. Macroscopic thrombus embolization in the infarct-related artery

Primary outcomes:
measure: Angiographic TIMI frame count
timeFrame: 2 minutes
measure: Minimal microcirculatory resistance (MMR)
timeFrame: 2 minutes
measure: Comparison of the MMR in the experimental group during the two-minutes saline infusion
timeFrame: 2 minutes
measure: Comparison of the Absolute coronary flow between the study groups.
timeFrame: 2 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Cadiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Madrid
country: Spain
facility: Hospital La Princesa
Study officials:
References:
citation: Ndrepepa G, Tiroch K, Keta D, Fusaro M, Seyfarth M, Pache J, Mehilli J, Schomig A, Kastrati A. Predictive factors and impact of no reflow after primary percutaneous coronary intervention in patients with acute myocardial infarction. Circ Cardiovasc Interv. 2010 Feb 1;3(1):27-33. doi: 10.1161/CIRCINTERVENTIONS.109.896225. Epub 2010 Jan 26.
citation: Airoldi F, Briguori C, Cianflone D, Cosgrave J, Stankovic G, Godino C, Carlino M, Chieffo A, Montorfano M, Mussardo M, Michev I, Colombo A, Maseri A. Frequency of slow coronary flow following successful stent implantation and effect of Nitroprusside. Am J Cardiol. 2007 Apr 1;99(7):916-20. doi: 10.1016/j.amjcard.2006.10.057. Epub 2007 Feb 12.
citation: Wijnbergen I, van 't Veer M, Lammers J, Ubachs J, Pijls NH. Absolute coronary blood flow measurement and microvascular resistance in ST-elevation myocardial infarction in the acute and subacute phase. Cardiovasc Revasc Med. 2016 Mar;17(2):81-7. doi: 10.1016/j.carrev.2015.12.013. Epub 2016 Jan 7.
citation: van 't Veer M, Adjedj J, Wijnbergen I, Toth GG, Rutten MC, Barbato E, van Nunen LX, Pijls NH, De Bruyne B. Novel monorail infusion catheter for volumetric coronary blood flow measurement in humans: in vitro validation. EuroIntervention. 2016 Aug 20;12(6):701-7. doi: 10.4244/EIJV12I6A114.
citation: Gibson CM, Schomig A. Coronary and myocardial angiography: angiographic assessment of both epicardial and myocardial perfusion. Circulation. 2004 Jun 29;109(25):3096-105. doi: 10.1161/01.CIR.0000134278.50359.CB. No abstract available.