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

NCT04685941 | Completed DMC

• 1 other identifier: EPIC24-RAIN-FLOW
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 5

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.

Conditions

Coronary Microvascular Disease; Myocardial Infarction

Keywords

Coronary Microvascular Disease; Myocardial Infarction

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Drug-mediated hyperemia

OTHER

Patients presenting with slow flow after PPCI undergo to at least 200 mcg of intracoronary nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes

Drug: Drug-mediated hyperemia

Flow-mediated hyperemia

EXPERIMENTAL

Patients presenting with slow flow after PPCI undergo to controlled saline intracoronary infusion by a dedicated microcatheter (RayFlow) at 20 ml/min during 2 minutes

Other: Flow-mediated hyperemia

Interventions

Drug-mediated hyperemia DRUG

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.

Drug-mediated hyperemia

Flow-mediated hyperemia OTHER

Intracoronary saline infusion at 20 ml/min via dedicated microcatheter (RayFlow; Hexacath, France) during two minutes.

Flow-mediated hyperemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación EPIC: lead
• Barcicore-Lab: collaborator

Study Sites (5)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital La Princesa

Madrid, 28006, Spain

Location

Related Publications (6)

• 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.

  PMID: 20118156 BACKGROUND

• 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.

  PMID: 17398183 BACKGROUND

• 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.

  PMID: 26905054 BACKGROUND

• 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.

  PMID: 27542781 BACKGROUND

• 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.

  PMID: 15226226 BACKGROUND

• Gomez-Lara J, Gracida M, Rivero F, Gutierrez-Barrios A, Muntane-Carol G, Romaguera R, Fuentes L, Marcano A, Roura G, Ferreiro JL, Teruel L, Brugaletta S, Alfonso F, Comin-Colet J, Gomez-Hospital JA. Treatment of Slow-Flow After Primary Percutaneous Coronary Intervention With Flow-Mediated Hyperemia: The Randomized RAIN-FLOW Study. J Am Heart Assoc. 2023 Jul 4;12(13):e030285. doi: 10.1161/JAHA.123.030285. Epub 2023 Jun 22.

  PMID: 37345805 DERIVED

MeSH Terms

Conditions

Microvascular Angina; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: January 25, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Locations

ES (5)