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

NCT ID: NCT07268391

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-12-31

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.

Detailed Description

Background and Rationale Acute myocardial infarction with ST-segment elevation (STEMI) continues to represent a major public health challenge, being one of the leading causes of morbidity and mortality worldwide. Advances in reperfusion therapy, particularly primary percutaneous coronary intervention (PCI), have substantially reduced short-term mortality rates. Nevertheless, a large proportion of patients experience adverse ventricular remodeling (AVR) during follow-up. AVR is characterized by pathological changes in left ventricular (LV) geometry, wall thinning, chamber dilation, and progressive decline in contractile function. These changes are strongly associated with the development of heart failure and increased long-term mortality.

Traditional imaging modalities, such as echocardiography and cardiac magnetic resonance (CMR), have been used to characterize post-infarction myocardial damage and to monitor remodeling. Echocardiography is widely available and provides important functional information, but it lacks the ability to characterize myocardial tissue in depth. CMR is currently the gold standard for infarct size quantification, detection of microvascular obstruction, and assessment of myocardial viability; however, it is costly, time-consuming, and not universally accessible. There remains an unmet need for more accessible, rapid, and accurate tools to predict AVR early after STEMI.

Spectral computed tomography (CT) has recently emerged as an innovative imaging technique that goes beyond conventional CT by providing spectral information and material decomposition. This technology enables enhanced tissue characterization, accurate quantification of myocardial perfusion defects, and identification of complications such as myocardial rupture or thrombus, all while using reduced contrast volume and lower radiation doses compared with older-generation scanners. Preliminary data suggest that spectral CT can approximate some of the information traditionally obtained through CMR, potentially offering a more accessible tool for post-infarction risk stratification.

In parallel, circulating microRNAs (miRNAs) have been identified as highly stable, non-invasive biomarkers involved in key biological processes relevant to cardiac remodeling, including fibrosis, apoptosis, angiogenesis, and inflammatory signaling. Several miRNAs have been associated with infarct size, LV dysfunction, and clinical outcomes in patients with acute myocardial infarction. Integrating molecular biomarkers with imaging could provide a powerful multiparametric model for early prediction of AVR, guiding patient-tailored therapeutic strategies.

The SPECTRAMI-CARE study (SPEctral CT and miRna In Acute Myocardial Infarction for Comprehensive Adverse Remodeling Evaluation) is designed as a prospective, multicenter observational cohort. The protocol aims to evaluate the complementary role of spectral CT and circulating miRNAs in predicting adverse remodeling after STEMI with impaired LV function.

Imaging Procedures

Spectral CT:

Performed within the first week after STEMI. Parameters include assessment of infarct size, perfusion defects, myocardial edema, and complications (e.g., thrombus, aneurysm). Quantitative indices will be derived from material decomposition images, iodine density maps, and virtual monoenergetic reconstructions.

Cardiac MRI (sub-cohort):

Used as a reference standard for infarct size, microvascular obstruction, and myocardial viability. Data will be compared with spectral CT findings for concordance and accuracy.

Echocardiography:

Performed at baseline and follow-up for routine functional assessment (LV volumes, LVEF, diastolic function, right ventricular parameters).

Molecular Biomarker Assessment Peripheral blood samples will be collected at baseline (≤72h after PCI), at 1 month, and at 3 months. miRNA profiling will be performed using next-generation sequencing and validated with quantitative RT-PCR. Candidate miRNAs previously implicated in fibrosis, apoptosis, angiogenesis, and remodeling will be specifically analyzed. Expression levels will be correlated with imaging findings and clinical outcomes.

Statistical Analysis Sample size will be based on expected incidence of AVR (~30% in high-risk STEMI populations). Multivariable logistic regression and Cox proportional hazards models will be used to identify predictors of AVR and clinical outcomes. Model performance will be evaluated using C-statistics, calibration plots, and net reclassification improvement (NRI). Internal validation will be performed with bootstrapping; external validation will be explored in an independent cohort.

Ethics and Dissemination The study will comply with the Declaration of Helsinki and local ethics regulations. Informed consent will be obtained from all participants. Data will be anonymized and stored securely. Results will be disseminated through peer-reviewed publications and presentations at scientific conferences, with the aim of contributing to precision medicine in post-infarction care.

Significance SPECTRAMI-CARE is expected to provide novel insights into the early identification of patients at risk for adverse remodeling after STEMI. By integrating cutting-edge imaging and molecular biomarkers, this study seeks to advance risk stratification and facilitate personalized strategies to improve outcomes. Spectral CT, if validated against CMR, may offer a more accessible alternative for myocardial tissue characterization, while circulating miRNAs may add a non-invasive layer of biological information. The multiparametric model proposed has the potential to change clinical practice by identifying high-risk patients earlier and enabling targeted therapeutic interventions.

Conditions

Acute Myocardial Infarction (AMI)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control group

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).

Group Type: ACTIVE_COMPARATOR

Blood analysis and spectral CT study

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

Blood analysis and spectral CT study

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Nacional de Investigaciones Cardiovasculares (CNIC)

Madrid, , Spain

Hospital La Princesa

Madrid, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Countries

Spain

Central Contacts

Candelas Pérez del Villar, MD in Cardiology

Role: CONTACT

mcperezvi@saludcastillayleon.es

+34923291200

Beatriz Martín Carro, PhD

Role: CONTACT

bmartincar.ibsal@saludcastillayleon.es

+34923291200

Facility Contacts

Carlos Galán Arriola, PhD

Role: primary

carlos.galan@cnic.es

914 53 12 00

Beatriz López Melgar, MD

Role: primary

blopezm@salud.madrid.org

915 20 22 00

Juan Manuel Monteagudo Ruiz, MD in Cardiology

Role: primary

j5469m@gmail.com

913 36 80 00

Candelas Perez del Villar, MD in Cardiology

Role: primary

mcperezvi@saludcastillayleon.es

+34923291200

Beatriz Martín Carro, PhD

Role: backup

bmartincar.ibsal@saludcastillayleon.es

Víctor Marcos Garcés

Role: primary

vic_mg_cs@hotmail.com

Other Identifiers

PI2025 03 1870

Identifier Type: OTHER

Identifier Source: secondary_id

SPECTRAMI-CARE

Identifier Type: -

Identifier Source: org_study_id