Normal Reference Values for 3T Cardiac Parametric Mapping

NCT06784427 | Completed

• 1 other identifier: NORMAP3T
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Imaging; Cardiac Imaging Techniques

Outcome Measures

Primary Outcomes (2)

• 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

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers with a negative history of established cardiac disease

You may qualify if:

• Healthy volunteers with a negative history of established cardiac disease
• years old
• Acquisition of informed consent

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40100, Italy

Location

Study Officials

• Edoardo Rasciti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 20, 2025
• Study Start: September 26, 2023
• Primary Completion: April 19, 2024
• Study Completion: April 19, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-11

Locations

IT (1)