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Coronary Microvascular DiseaseRAIN FLOWNCT04685941

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

A study testing Drug-mediated hyperemia and Flow-mediated hyperemia in people with Coronary Microvascular Disease and Myocardial Infarction, run by Fundación EPIC at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Drug-mediated hyperemia and Flow-mediated hyperemia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
5 sitesSpain
Study dates
25 Jan 2021to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital La Princesa

    Madrid, 28006

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Drug-mediated hyperemia, Flow-mediated hyperemia
Keywords
Coronary Microvascular Disease, Myocardial Infarction
Medical subject headings
Microvascular Angina, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Drug-mediated hyperemiaDrug

    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.

  • Flow-mediated hyperemiaOther

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

Study groups in NCT04685941
Study groupRoleWhat they receive
Drug-mediated hyperemiaOtherPatients presenting with slow flow after PPCI undergo to at least 200 mcg of intracoronary nitroprussiate or 500 mcg of intracoronary adenosine during 2 minutes
Receives: Drug: Drug-mediated hyperemia
Flow-mediated hyperemiaExperimentalPatients presenting with slow flow after PPCI undergo to controlled saline intracoronary infusion by a dedicated microcatheter (RayFlow) at 20 ml/min during 2 minutes
Receives: Other: Flow-mediated hyperemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 2 minutes

  2. 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).

    Measured: 2 minutes

  3. 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.

    Measured: 2 minutes

  4. 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.

    Measured: 2 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2020
  2. Study start25 Jan 2021
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685941
Sponsor's protocol ID
EPIC24-RAIN-FLOW
Acronym
RAIN FLOW
Status last verified
Nov 2022
First submitted
22 Dec 2020
Last updated
10 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20118156

  • 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.

    PubMed 17398183

  • 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.

    PubMed 26905054

  • 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.

    PubMed 27542781

  • 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.

    PubMed 15226226

  • 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.

    PubMed 37345805

Questions about this trial

What is this clinical trial studying?

A study testing Drug-mediated hyperemia and Flow-mediated hyperemia in people with Coronary Microvascular Disease and Myocardial Infarction, run by Fundación EPIC at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Angiographic TIMI frame count (time frame: 2 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04685941, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.

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