---
title: Coronary Physiology Testing in Acute Coronary Syndromes
nct_id: NCT04677257
overall_status: COMPLETED
phase: NA
sponsor: IRCCS San Raffaele
study_type: INTERVENTIONAL
primary_condition: ST Elevation Myocardial Infarction
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04677257.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04677257"
ct_last_update_post_date: 2023-10-04
last_seen_at: "2026-05-12T07:15:37.684Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Coronary Physiology Testing in Acute Coronary Syndromes

**NCT ID:** [NCT04677257](https://clinicaltrials.gov/study/NCT04677257)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 130
- **Lead Sponsor:** IRCCS San Raffaele
- **Conditions:** ST Elevation Myocardial Infarction
- **Start Date:** 2020-11-02
- **Completion Date:** 2022-12-31
- **CT.gov Last Update:** 2023-10-04

## Brief Summary

This is an interventional, prospective, multicenter study (5 IRCCS hospitals belonging to the Italian Cardiology Network) in patients with STEMI treated with successful primary PCI to assess the ability of coronary physiology parameters measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (CMR) within a week of the acute event. Furthermore, patients will be followed up for a period of 12 months to assess the incidence of major adverse cardiovascular events (death, death from cardiovascular causes, re-infarction, new coronary revascularization interventions, development of heart failure) based on their stratification according to coronary physiology parameters.

## Detailed Description

In the present study the investigators will enroll consecutive patients with STEMI acute myocardial infarction treated with successful primary PCI, to assess the ability of coronary physiology parameters, i.e. coronary flow reserve (CFR) and index of microvascular resistance (IMR) measured after recanalization to predict myocardial tissue characterization (MVO, MSI, IS, T2-rt, T1-rt and ECV) assessed with contrast CMR within a week of the acute event. Furthermore, the relationship between left ventricular end-diastolic pressure and of coronary physiology parameters will be evaluated.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients with STEMI (defined according to ESC Guidelines 2017), with symptom onset within 12 hours (Class I), or between 12 and 48 hours (Class IIa), (1) successfully treated with primary PCI. (1)

Exclusion Criteria:

1. Patients with previous myocardial infarction in the territory of the infarct-related artery;
2. Patients with previous coronary artery bypass grafting;
3. Patients with cardiogenic shock at presentation;
4. Patients with need for mechanical support of the circulation;
5. Patients with known severe aortic stenosis / insufficiency;
6. Patients with known cardiomyopathy;
7. Patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
8. Patients affected by known active infectious diseases;
9. Women who are pregnant or breastfeeding;
10. Patients who are unable to express valid informed consent upon enrollment;
11. Patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine);
12. Patients with specific contraindications to cardiac magnetic resonance imaging, including:

    * Patients with allergies and / or with other specific contraindications to the use of paramagnetic contrast media (gadolinium), including chronic renal failure with glomerular filtrate (eGFR) \<30 mL / min;
    * Patients with non-resonance-compatible devices or who have undergone previous surgical interventions with placement of non-resonance-compatible vascular clips;
    * Claustrophobic patients.
```

## Arms

- **STEMI acute myocardial infarction treated with effective primary PCI** (EXPERIMENTAL) — STEMI patients treated with effective primary PCI to assess the ability of coronary physiology parameters (CFR and IMR) measured soon after recanalization to predict myocardial tissue characterization assessed with cardiac magnetic resonance (CMR) within a week of the acute event.

## Interventions

- **PCI, invasive coronary physiology and CMR** (PROCEDURE) — Patients with acute STEMI will undergo invasive assessment of coronary physiology (IMR and CFR) following successful primary PCI and CMR within a week of the acute event

## Primary Outcomes

- **Defining the predictive value of the classification of patients based on coronary physiology** _(time frame: 5 ± 2 days of the acute event.)_ — Establish the predictive value of the classification of patients based on coronary physiology measured in acute after primary PCI in patients with STEMI, on the incidence of microvascular obstruction (MVO) measured with CMR with contrast medium within 5 ± 2 days of the acute event.

## Locations (5)

- IRCCS AOU San Martino, Genova, Italy
- IRCCS Ospedale San Raffaele, Milan, Italy
- IRCCS Centro Cardiologico Monzino, Milan, Italy
- IRCCS Policlinico Gemelli, Roma, Italy
- IRCCS Multimedica, Sesto San Giovanni, Italy

## Recent Field Changes (last 30 days)

- `locations.irccs multimedica|sesto san giovanni||italy` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.irccs aou san martino|genova||italy` — added _(2026-05-12)_
- `locations.irccs ospedale san raffaele|milan||italy` — added _(2026-05-12)_
- `locations.irccs centro cardiologico monzino|milan||italy` — added _(2026-05-12)_
- `locations.irccs policlinico gemelli|roma||italy` — added _(2026-05-12)_

---

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