Using Advanced CT Scans and Blood Markers to Better Understand Heart Damage and Recovery After a Heart Attack

NCT07268391 | Not Yet Recruiting

• 2 other identifiers: SPECTRAMI-CAREPI2025 03 1870
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 5

Brief Summary

Acute myocardial infarction with ST-segment elevation (STEMI) remains a leading cause of morbidity and mortality worldwide. Although advances in reperfusion therapy have reduced early mortality, many patients later develop adverse ventricular remodeling (AVR), which increases the risk of heart failure and cardiovascular death. Current imaging methods, such as echocardiography and cardiac magnetic resonance (CMR), provide valuable prognostic information but have limitations in availability, cost, and their ability to predict AVR early and individually. Spectral computed tomography (CT) is an emerging imaging technique that can characterize myocardial tissue, quantify infarct size, assess microvascular obstruction, and detect complications, with lower contrast and radiation requirements compared to conventional CT. In parallel, circulating microRNAs (miRNAs) have been identified as stable and non-invasive biomarkers that reflect key biological processes in post-infarction remodeling. Several miRNAs are linked to fibrosis, apoptosis, and ventricular remodeling, suggesting their potential to complement imaging findings in risk prediction. This study proposes a multicenter, prospective cohort of patients with STEMI and reduced left ventricular function to evaluate whether combining spectral CT tissue characterization with serum miRNA profiling can improve early prediction of AVR. The main objective is to generate and validate a multiparametric prognostic model integrating imaging and molecular biomarkers to identify high-risk patients who may benefit from closer monitoring and tailored therapeutic strategies.

Conditions

Acute Myocardial Infarction (AMI)

Keywords

magnetic resonance; miRNA; myocardial infarction; adverse ventricular remodeling; spectral computed tomography

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse ventricular remodeling at 6 months, defined as an increase in LV end-diastolic volume ≥20% compared with baseline.

  The primary endpoint will be the occurrence of adverse ventricular remodeling (AVR) as assessed by cardiac magnetic resonance imaging (CMR). AVR will be defined as an increase in left ventricular end-diastolic volume (LVEDV) of ≥20% compared with baseline values obtained during the acute phase (3-7 days post-STEMI). In cases where CMR is not feasible, spectral CT-derived LV volumes will be used as a contingency reference, given their validated correlation with CMR measurements.

  6 months

Secondary Outcomes (9)

• Infarct size characterization by spectral CT vs. CMR.

  Baseline and 6 months

• Myocardial characterization by spectral CT vs. CMR.

  Baseline and 6 months

• Correlation of miRNA signatures with remodeling.

  Baseline and 6 months

• Predictive accuracy of integrated models (spectral CT + miRNA vs. conventional predictors)

  6 months

• Major adverse cardiovascular events (MACE)

  From baseline to 6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

At the coordinating center (CAUSA), a control group (n = 20) will be included, consisting of patients with a clinical indication for cardiac CT for reasons other than myocardial infarction, meeting the following criteria: absence of myocardial injury or structural heart disease, ≤1 cardiovascular risk factor, LVEF \> 55%, and no significant valvular disease (grade \< III).

Procedure: Blood analysis and spectral CT study

Adult patients experiencing a first ST-segment elevation myocardial infarction (STEMI)

EXPERIMENTAL

Patientes will be included in this group if the following requirements are met: Hospital admission due to STEMI, treated in accordance with current clinical practice guidelines. Left ventricular systolic dysfunction, defined as a left ventricular ejection fraction (LVEF) \< 50%, assessed by transthoracic echocardiography (TTE) within the first 24-72 hours of admission. Provision of signed informed consent.

Procedure: Blood analysis, spectral CT scan and cardiac magnetic resonance imaging (CMR) study

Interventions

Blood analysis, spectral CT scan and cardiac magnetic resonance imaging (CMR) study PROCEDURE

After providing informed consent, patients will undergo blood sampling, a spectral CT scan scheduled between the 3rd and 7th day of hospitalization (acute phase), and a cardiac magnetic resonance imaging (CMR) study performed within a maximum of 72 hours from the CT.

Adult patients experiencing a first ST-segment elevation myocardial infarction (STEMI)

Blood analysis and spectral CT study PROCEDURE

Patients who meet the inclusion criteria for the control group will be invited to participate in the study. They will undergo blood sampling and the planned spectral CT study, including a late iodine enhancement acquisition.

Control group

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years.
• First STEMI treated with primary PCI.
• Left ventricular ejection fraction (LVEF) ≤45% during index hospitalization.
• Ability to provide informed consent.

You may not qualify if:

• Contraindication to iodinated contrast media.
• Chronic kidney disease with eGFR \<30 mL/min/1.73 m².
• Prior myocardial infarction or known cardiomyopathy.
• Contraindication to CT or MRI imaging.
• Life expectancy \<1 year due to non-cardiac conditions.

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead

Study Sites (5)

Centro Nacional de Investigaciones Cardiovasculares (CNIC)

Madrid, Spain

Location

Hospital La Princesa

Madrid, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, Spain

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Candelas Pérez del Villar, MD in Cardiology

CONTACT

+34923291200; mcperezvi@saludcastillayleon.es

Beatriz Martín Carro, PhD

CONTACT

+34923291200; bmartincar.ibsal@saludcastillayleon.es

Study Design

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

Model Details: This is a multicenter, observational study with prospective enrollment of adult patients experiencing a first ST-segment elevation myocardial infarction (STEMI) (n = 95), according to the following inclusion criteria: * Hospital admission due to STEMI, treated in accordance with current clinical practice guidelines. * Left ventricular systolic dysfunction, defined as a left ventricular ejection fraction (LVEF) \< 50%, assessed by transthoracic echocardiography (TTE) within the first 24-72 hours of admission. * Provision of signed informed consent. At the coordinating center (CAUSA), a control group (n = 20) will be included, consisting of patients with a clinical indication for cardiac CT for reasons other than myocardial infarction, meeting the following criteria: absence of myocardial injury or structural heart disease, ≤1 cardiovascular risk factor, LVEF \> 55%, and no significant valvular disease (grade \< III).

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Beginning 12 months after publication of primary results, available for at least 5 years.
• Access Criteria: Access Criteria: Access will be granted to qualified researchers with a methodologically sound proposal. Requests will be reviewed by the study Data Committee/steering committee. Applications must be addressed to the PI (Candelas Pérez del Villar). Requirements include: Data Use Agreement (DUA), commitment to non-reidentification, appropriate data security, mandatory citation of dataset source and DOI. Analytical code sharing and a publication plan may be required prior to access approval. IPD Sharing Support: Data will be hosted on controlled project infrastructure (XNAT/Core-lab) and disseminated through the IBSAL Zenodo community with DOI and regulated access, in compliance with GDPR/LOPDGDD and CEIm approval.

Locations

ES (5)