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OpenTrials
Completed

NCT Number: NCT04677257

Coronary Physiology Testing in Acute Coronary Syndromes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS AOU San Martino, Genova, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Patients with previous myocardial infarction in the territory of the infarct-related artery;
  • Patients with previous coronary artery bypass grafting;
  • Patients with cardiogenic shock at presentation;
  • Patients with need for mechanical support of the circulation;
  • Patients with known severe aortic stenosis / insufficiency;
  • Patients with known cardiomyopathy;
  • Patients with malignant neoplasm or systemic pathology with a "quoad vitam" prognosis of less than 1 year;
  • Patients affected by known active infectious diseases;
  • Women who are pregnant or breastfeeding;
  • Patients who are unable to express valid informed consent upon enrollment;
  • Patients with hypersensitivity to the active ingredients used for the study of coronary physiology (nitrates and adenosine);
  • 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.

Treatment and study plan

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

  1. 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.

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Acronym: CoPhyTea

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Dec 21, 2020
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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