Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia

Myocardial Infarction Clinical Trial

— RAIN FLOW  

Official title:

Treatment of Slow-flow After Primary Percutaneous Coronary Intervention With Flow-mediated Hyperemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04685941
• Other study ID #: EPIC24-RAIN-FLOW
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: Fundación EPIC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Hyperemia
• Infarction
• Microvascular Angina
• Myocardial Infarction

Intervention

Drug:
• Drug-mediated hyperemia
Intracoronary bolus of at least 200 mcg of nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes. Operators are allowed to combine both drugs.

Other:
• Flow-mediated hyperemia
Intracoronary saline infusion at 20 ml/min via dedicated microcatheter (RayFlow; Hexacath, France) during two minutes.

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario Puerta del Mar	Cadiz
Spain	Hospital Universitari de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital La Princesa	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundación EPIC	Barcicore-Lab

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. Epub 2007 Feb 12. — View Citation

Gibson CM, Schömig A. Coronary and myocardial angiography: angiographic assessment of both epicardial and myocardial perfusion. Circulation. 2004 Jun 29;109(25):3096-105. Review. — View Citation

Ndrepepa G, Tiroch K, Keta D, Fusaro M, Seyfarth M, Pache J, Mehilli J, Schömig 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. — View Citation

van 't Veer M, Adjedj J, Wijnbergen I, Tóth 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic TIMI frame count	Cine-fluoroscopic recording of the infarct-related artery (IRA) at 30 frames/second and off-line core-laboratory assessment of the number of cineframes needed for dye to reach standardized distal landmarks is the coprimary endpoint. Long TIMI frame counts are indicative of slow coronary flow. Previous studies showed TIMI frame counts of 30 (SD 12) after nitroprussiate in slow flow STEMI patients. The present study is powered to assess 25 percent difference between study groups (80 percent power and 5 percent alfa error).	2 minutes
Primary	Minimal microcirculatory resistance (MMR)	MMR is assessed by intracoronary thermodilution with a dedicated pressure wire and microcatheter (RayFlow, Hexacath) during saline infusion at 20 ml/min. MMR is measured offline by the core-laboratory at 20 seconds of the saline infusion in the standard medical treatment group and at 2 minutes and 20 seconds in the experimental group. According to previous studies, MMR was 537 Wood units (SD 289). The present study is powered to assess 30 percent difference between study groups after study intervention (80 percent power and 5 percent alfa error).	2 minutes
Primary	Comparison of the MMR in the experimental group during the two-minutes saline infusion	Experimental treatment with saline infusion via microcatheter is performed continuously recording the pressure and temperature values of the culprit artery. Off-line core-laboratory assessment of the MMR will be performed at 20 seconds and at 2 minutes of the saline infusion.	2 minutes
Primary	Comparison of the Absolute coronary flow between the study groups.	Absolute coronary flow is performed simultaneously with the MMR. This value shows the coronary blood flow of the culprit artery during maximal hyperemia.	2 minutes