NCT04680689

Brief Summary

The aim of the Fused-Heart study is to investigate the impact of a coronary artery stenosis on myocardial function and viability, based on advanced fusion imaging techniques derived from CCTA. Moreover the study will investigate the correlation between morphology and composition of atheromatous plaques located in a coronary artery and myocardial ischemia in the territory irrigated by the same coronary artery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

July 30, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

December 14, 2020

Last Update Submit

February 11, 2023

Conditions

Myocardial IschemiaMyocardial ViabilityCoronary StenosisVulnerable Coronary Plaques

Keywords

Fusion imagingCCTAMyocardial viabilityVulnerable coronary plaques

Outcome Measures

Primary Outcomes (1)

  • MACE rate-Major Adverse Cardiovascular Events

    The primary outcome of the study is represented by the rate of MACE events related to myocardial ischemia at 1-year post assessment, in correlation with the degree of coronary artery stenosis and myocardial ischemia or viability.

    12 months

Secondary Outcomes (2)

  • Re-hospitalisation rate,

    12 months

  • Rate of survival

    12 months

Study Arms (2)

Fuse-Heart -SG 01

Study subjects with anatomically significant coronary lesions (at least 50% luminal narrowing) on native coronary arteries.

Diagnostic Test: 128 Multislice CT coronary angiographyDiagnostic Test: 2D Cardiac Transthoracic EchocardiographyDiagnostic Test: Laboratory Blood tests

Fuse-Heart -SG 02

Study subjects surviving an acute myocardial infarction, revascularized or not.

Diagnostic Test: 128 Multislice CT coronary angiographyDiagnostic Test: 2D Cardiac Transthoracic EchocardiographyDiagnostic Test: Laboratory Blood tests

Interventions

128 Multislice CT coronary angiographyDIAGNOSTIC_TEST

128 Multislice CT coronary angiography with the evaluation of coronary stenosis, the plaque vulnerability markers ( necrotic core, low attenuation plaque, spotty calcifications, napkin ring sign, positive remodeling), asses polar maps of the myocardium

Also known as: CCTA
Fuse-Heart -SG 01Fuse-Heart -SG 02
2D Cardiac Transthoracic EchocardiographyDIAGNOSTIC_TEST

2D Cardiac Transthoracic Echocardiography with the evaluation of the cardiac cavity dimensions

Fuse-Heart -SG 01Fuse-Heart -SG 02
Laboratory Blood testsDIAGNOSTIC_TEST

Laboratory tests for evaluations the level of inflammatory biomarkers ( hs-CRP, MMP, IL6 and NT-pro-BNP), complete blood count, biochemestry

Fuse-Heart -SG 01Fuse-Heart -SG 02

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will include 100 subjects with coronary lesions depicted by CCTA examination. The study population will consist in: (1) patients with anatomically significant coronary lesions (at least 50% luminal narrowing) on native coronary arteries, or (2) patients surviving an acute myocardial infarction, revascularized or not.

You may qualify if:

  • Patients undergoing CCTA examination, with at least one coronary artery lesion producing a luminal narrowing \>50%
  • Ability to provide informed consent;
  • Patients aged at least 18 years;

You may not qualify if:

  • Unwillingness or incapacity to provide informed consent;
  • Allergy to contrast media;
  • Absolute or relative contraindications to CCTA imaging;
  • Irregular or rapid heart rhythm
  • Pregnancy or lactation;
  • Women with childbearing potential in absence of any contraceptive treatment;
  • Renal insufficiency (creatinine greater than 1.5 mg/dL) or renal failure requiring dialysis;
  • Active malignancy or malignancy within the last 5 year prior to enrollment;
  • Conditions associated with an estimated life expectancy of under 2 years;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardio Med Medical Center

Târgu Mureş, Mureș County, 540102, Romania

Location

Biospecimen

Retention: SAMPLES WITH DNA

venous blood samples for complete blood count, biochemistry, inflammatory biomarkers

MeSH Terms

Conditions

Myocardial IschemiaCoronary Stenosis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesCoronary Disease

Study Officials

  • Alexandra Gorea Stanescu, MD

    Cardio Med

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 23, 2020

Study Start

July 30, 2021

Primary Completion

December 1, 2022

Study Completion

January 1, 2023

Last Updated

February 14, 2023

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication will be available for interested parties

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The IPD sharing time is starting 6 months aflter publication

Locations

RO(1)