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Trial · NCT07380919

Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study

NCT07380919, Phase 2, Phase 3, Recruiting, Federico II University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study. Trials, record NCT07380919. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07380919

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Inhibition of Late Sodium Current (INa) to Prevent Coronary MICROvascular Dysfunction in Patients Presenting With ST-Elevation Myocardial Infarction and Multivessel Disease: INaMICRON Study
NCT number
NCT07380919
Status
Recruiting
Phases
Phase 2, Phase 3
Enrollment
100 participants, estimated
Lead sponsor
Federico II University
Conditions
STEMI (ST Elevation MI)
Interventions
Ranolazine
First posted
2026-02-02
Last updated
2026-03-11

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryPreservation of the coronary microcirculationUp to 8 weeks
he relative difference in terms of IMR and/or angioIMR will be evaluated. IMR and/or angioIMR will be assessed both at the baseline (after successful coronary revascularization) and at the time of staged revascularization of the non-culprit stenosis (either at 5+/-2 days or within 6+/-2 weeks after pPCI).
SecondaryDifference in terms of CMD prevalence between the two groupsUp to 8 weeksThe prevalence of residual CMD downstream to the culprit vessel in the two group of patients. Residual CMD will be defined as the finding of an IMRculprit or angioIMRculprit value \> 25
SecondaryInfarct Size ExtensionUp to 8 weeksThe extent of the Infarct Size, as assessed by the CMR, in terms of grams (g) and percentage as compared with control group
SecondaryCMD prevalence downstream to the non-culprit vessel before staged PCIUp to 8 weeks
The prevalence of CMD downstream to the non-culprit vessel in the two group of patients (CMDnon-culprit). CMDnon-culprit will be defined as the finding of an IMRnon-culprit or angioIMRnon-culprit value \> 25
SecondaryCMD prevalence after staged PCIUp to 8 weeks
The incidence of peri-procedural CMD after staged PCI of the non-culprit stenoses, defined as a 20% increase of IMRnon-culprit or angioIMRnon-culprit values assessed before and after elective PCI of the non-culprit vessel.
SecondaryIncidence of periprocedural MI eventually occurring after staged proceduresUp to 8 weeks
The difference between the two groups of patients, in terms of incidence of periprocedural Myocardial Infarction (PMI), eventually occurring during the staged procedure. PMI require to satisfy all the criteria of the fourth Universal Definition of Myocardial Infarction
SecondaryIncidence of MACEUp to 8 weeksThe incidence of MACE, defined as composite of death, myocardial infarction, or target-vessel revascularization at short (42+/-7 days) term follow-up.
SecondaryResidual angina symptomsUp to 8 weeks
Angina symptoms will be assessed with The SAQ-7 (Seattle Angina Questionnaire-7) summary score which is a 0-100 validated measure of coronary artery disease (CAD) patient health status, averaging Physical Limitation, Angina Frequency, and Quality of Life domains. Higher scores (0-100) indicate better health status, less frequent angina, and improved quality of life and results compared between the two groups.
SecondaryPatients' Quality of LifeUp to 8 weeks
Quality of life will be assessed with the EQ5D5L including a vertical visual analogue scale (EQ VAS) that allows patients to self-rate their current, overall health-related quality of life from 0 ("worst imaginable health") to 100 ("best imaginable health").
SecondaryIncidence of endothelial dysfunctionUp to 8 weeks
The effects of INa current inhibition on endothelial function will be assessed at follow up as compared with control group. Endothelial function will be evaluated with the EndoPAT, measuring both the Endoscore and RHI

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers49

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
7873471BACKGROUNDPubMed
12821539BACKGROUNDPubMed
14734593BACKGROUNDPubMed
15093870BACKGROUNDPubMed
15103605BACKGROUNDPubMed
15165914BACKGROUNDPubMed
15238822BACKGROUNDPubMed
15582310BACKGROUNDPubMed
16636168BACKGROUNDPubMed
16980514BACKGROUNDPubMed

1 to 10 of 49

See all 49 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07380919

GET https://conductscience.org/api/trials/v1/NCT07380919/papers?page=2