Clinical trial NCT04680689: Assessment of Lesion-Associated Myocardial Ischemia Based on Fusion Coronary CT Imaging
Official title: Assessment of Lesion-Associated Myocardial Ischemia Based on Fusion Coronary CT Imaging- the FUSE-HEART Study: Protocol for a Non-randomised Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Ischemia
Myocardial Viability
Coronary Stenosis
Vulnerable Coronary Plaques
Keywords: Fusion imaging
CCTA
Myocardial viability
Vulnerable coronary plaques
Lead sponsor: Cardio Med Medical Center
Sponsor class: INDUSTRY
Collaborators: name: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
name: Tîrgu Mureș Emergency Clinical County Hospital, Romania
First posted: 2020-12-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: The FUSE-HEART study is a prospective, observational, single-center, cohort study that will be conducted in the Laboratory of Advanced Research in Cardiac Multimodal Imaging of Cardio Med Medical Center Targu Mures, Romania.

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. In all patients, presence of vulnerability features in the atheromatous plaques will be studied and the vulnerability score will be calculated for each plaque, consisting in one point added for each of the following vulnerability markers: positive remodeling, napkin-rink sign, presence of low density plaque or spotty calcium within the plaque. In addition, following 3D fusion of the images of the coronary tree with the images reflecting wall motion, the correspondence between plaque morphology and composition on one hand, and wall motion in the corresponding distribution territory of that coronary artery, will be studied based on fused models.

The study will be conducted over a period of 2 years, in which patients will be examined at baseline, with a projected recruitment period of 1 year and will be followed-up 1 year for MACE.

Study objectives:

Primary: to investigate the impact of a coronary artery stenosis on myocardial function and viability, based on advanced fusion imaging techniques derived from CCTA.

Secondary: to 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.

Study timeline:

• Baseline (day 0)-Obtain and document consent from participant on study consent form.

Verify inclusion/exclusion criteria. Obtain demographic information, medical history, medication history, alcohol and tobacco use history. Record results of physical examinations and 12-lead ECG.Collect blood specimens (complete blood count, biochemistry and inflammatory biomarkers).Imaging procedures: CCTA-Image processing - quantification of coronary stenosis, characterization of vulnerability markers, 3D reconstruction, extension and characterization of wall motion. Deliver fused 3D images

• Visit 1 (month 1)-Record results of physical examinations, 12-lead ECG, blood pressure, and medical history. MACE assessment Visit 2 (month 3) -Telephone visit with target questions, all the answers recorded in study forms Visit 3 (month 6) - Record results of physical examinations, 12-lead ECG, blood pressure, and medical history. MACE assessment

Final study visit (month 12)- Record results of physical examinations, medical history,12-lead ECG, blood pressure, transthoracic 2-D echocardiography. End-point and MACE evaluation.

Study procedures:

* Medical history, clinical examination, laboratory tests (complete blood count, biochemistry, inflammatory biomarkers: hs-CRP, MMP, IL6 and NT-pro-BNP);
* 12-lead ECG
* 2D transthoracic echocardiography
* CCTA
* Computerized postprocessing and fused images

Data collection:

All the information will be collected in a dedicated database including medical history, medication, imaging features provided by cardiac ultrasound, CCTA and fused images resulting from imaging post-processing.

Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;

Primary outcomes:
measure: MACE rate-Major Adverse Cardiovascular Events
timeFrame: 12 months
Secondary outcomes:
measure: Re-hospitalisation rate,
timeFrame: 12 months
measure: Rate of survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Targu Mures
country: Romania
facility: Cardio Med Medical Center
state: Mures
Study officials:
affiliation: Cardio Med
name: Alexandra Gorea Stanescu, MD
role: PRINCIPAL_INVESTIGATOR
References: