Normal Reference Values for 3T Cardiac Parametric Mapping (NORMAP3T)

This is a study non-randomised and uncontrolled cross-sectional experimental/interventional study.

Consecutive subjects will be enrolled healthy, volunteer subjects to undergo a Cardio-RM examination on the new 3T MRI equipment.

The Cardio-RM examination to which they will undergo: does NOT involve the administration of contrast medium involves the performance of certain preliminary 'localisation' sequences.

Following the execution of the investigation the investigators will use the post-processing workstations to analyse the parametric sequences and extract the T1 and T2 values of the myocardium.

To minimise bias, two different investigators different experimenters independently evaluate the sequences, in order to assess inter-observer agreement; furthermore, to assess the stability of the acquisition of these sequences, temperature and humidity will be measured of the MRI room for each survey performed.

Study Overview

• Status: Completed
• Conditions: Cardiac Imaging Techniques; Cardiac Imaging

Detailed Description

Cardiac MRI represents the gold standard for the in vivo differentiation of various types of cardiomyopathies, thanks to its ability to characterize tissue. Through specific parametric mapping sequences, cardiac MRI allows not only the identification but also the quantification of both focal and diffuse alterations that cannot be assessed with other techniques. These sequences enable the direct measurement of relaxation times T1 (spin-lattice) and T2 (spin-spin), expressed in milliseconds, thus providing the ability to differentiate various tissue alterations (e.g., inflammation, ischemia, edema, and fibrosis).

The usefulness of T1 mapping sequences in analyzing certain cardiomyopathies, such as cardiac involvement in Anderson-Fabry disease, amyloidosis, and hemochromatosis, is well-documented in the literature. Similarly, T2 mapping sequences are valuable for evaluating inflammatory processes and myocarditis. Parametric sequences are also used to assess rejection phenomena in patients undergoing cardiac transplantation and play a crucial role in evaluating various cardiomyopathies in their end-stage phases.

Despite the broad and promising applications of these sequences as reported in the literature, certain challenges persist in their use. Specifically, the normal values for these sequences vary depending on the type of sequence and the specific MRI equipment employed. In our department, these sequences have been routinely used in clinical practice with a 1.5T MRI machine, for which the normal values have already been established and documented. With the recent installation of a new 3T MRI system, it is therefore necessary to determine the normal values of parametric sequences in healthy subjects to enable their use in routine clinical practice and for research purposes involving patients with various types of cardiomyopathies.

• Study Type: Observational
• Enrollment (Actual): 143

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40100
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers with a negative history of established cardiac disease

Description

Inclusion Criteria:

1. Healthy volunteers with a negative history of established cardiac disease
2. 20-70 years old
3. Acquisition of informed consent

Exclusion Criteria:

1. Positive family history of known cardiomyopathies, sudden cardiac death
2. Taking specific chronic therapy for diabetes and hypertension with ≥ 2 drugs and/or
3. Cardio-vascular risk factors: obesity, hypertension on ≥ 2 drugs, smoking (>10 cigarettes/day)
4. Competitive sports subjects or athletes (defined as >9 hours of sports activity/week)
5. Pregnant women
6. Claustrophobic subjects
7. Other absolute contraindications to MRI
8. Subjects with a relationship of direct/indirect subordination from the Radiology Unit, IRCCS - Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Normal T1 mapping values at 3T	To establish the normal values of the T1 mapping with a 3T MRI in healthy subjects, measuring the mean and standard deviation of the values obtained from the specific sequence	Form date of examination until 3 months
Normal T2 mapping values at 3T	To establish the normal values of the T2 mapping with a 3T MRI in healthy subjects, measuring the mean and standard deviation of the values obtained from the specific sequence	Form date of examination until 3 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Edoardo Rasciti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Actual): April 19, 2024
• Study Completion (Actual): April 19, 2024

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NORMAP3T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No