Unmasking the Prevalence of AC in an Unselected Echocardiographic Population (AC-TIVE)

February 3, 2021 updated by: Marco Merlo, University of Trieste

A National Survey of Prevalence and Accuracy of Echocardiographic Red Flags of Amyloid Cardiomyopathy in Consecutive Patients Undergoing Routine Echocardiography.

This study will investigate the prevalence of echocardiographic red-flags of amyloid cardiomyopathy (AC) in patients undergoing clinically-indicated echocardiography (observational phase) and the prevalence of AC among AC-suggestive echocardiograms (interventional phase).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective multicenter Italian survey consisting of two phases: observational (echocardiographic screening for amyloid cardiomyopathy among patients ≥ 55 years undergoing clinically-indicated echocardiography) and interventional (specific clinical and instrumental work-up to detect the prevalence of amyloid cardiomyopathy among amyloid cardiomyopathy-suggestive echocardiograms).

Study Type

Observational

Enrollment (Actual)

381

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70121
        • Cardiology Unit, Department of Emergency and Organ Transplantation, University of Bari Aldo Moro
      • Bologna, Italy, 40138
        • Cardiovascular Department, Policlinico Sant'Orsola
      • Brescia, Italy, 25100
        • Cardiology, Department of Medical and Surgical Specialities, Radiological Sciences and Public Health - University of Brescia
      • Ferrara, Italy, 44121
        • Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara
      • Firenze, Italy, 50134
        • Cardiomyopathy Unit, Careggi University Hospital
      • Genova, Italy, 16126
        • Cardiovascular Unit, Department of Internal Medicine, University of Genova
      • Messina, Italy, 98122
        • Department of Cardiology, University of Messina
      • Milano, Italy, 20126
        • Department of medicine and surgery, University Milano-Bicocca
      • Milano, Italy, 20149
        • Department of Cardiovascular, Neural and Metabolic Sciences - Istituto Auxologico Italiano
      • Napoli, Italy, 80131
        • Department of Translational Medical Sciences, Inherited and Rare Heart Disease, Vanvitelli Cardiology, University of Campania Luigi Vanvitelli
      • Pisa, Italy, 56127
        • Istituto di Scienze della Vita, Scuola Superiore Sant'Anna
      • Roma, Italy, 00155
        • Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology, Sapienza University
      • Siena, Italy, 53100
        • Division of Cardiology, University of Siena
      • Torino, Italy, 10126
        • University Cardiology A.O.U., Città della Salute e della Scienza di Torino
      • Trieste, Italy, 34149
        • Centre for Diagnosis and Treatment of Cardiomyopathies, Cardiovascular Department, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI)
    • Milano
      • Pavia, Milano, Italy, 27100
        • Emergency Department and Amyloid Research and Treatment Center, IRCCS Policlinico San Matteo Foundation, Department of Internal Medicine, University of Pavia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive inpatients and outpatients subjects aged ≥55 years undergoing routine, clinically-indicated echocardiography at the laboratories of participating centers.

Description

Inclusion Criteria:

All the following:

  • Interventricular septum thickness ≥ 13 mm in men and ≥ 12 mm in women;
  • Left ventricular ejection fraction ≥ 50%;
  • Indexed end-diastolic left ventricular volume ≤ 85 mL/m2.

AND

At least one of the following criteria:

  • "Granular sparkling" appearance of the myocardium defined granular texture with uniform increased brightness of echo-reflections;
  • Pericardial effusion regardless of severity;
  • Increased interatrial septum thickness (> 5 mm);
  • Restrictive filling pattern (Dec. Time E wave <120 ms or Dec. Time E wave ≤150 ms e E/A ratio ≥2) or increased ventricular filling pressures (E/E'15);
  • Speckle tracking derived global longitudinal strain with apical sparing pattern;
  • Increased thickness (> 5 mm) of mitral and tricuspid valve leaflets.

Exclusion Criteria:

  • Patients aged < 55 years or > 100 years
  • Echocardiography performed due to known or suspected amyloid cardiomyopathy;
  • Echocardiography performed due to known hypertrophic cardiomyopathy or phenocopies;
  • Refuse to sign the informed consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of Amyloid Cardiomyopathy
Time Frame: 3 months
The prevalence of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged > 55 years
3 months
The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy
Time Frame: 6 months
The prevalence of echocardiographic red flags of Amyloid Cardiomyopathy in unselected echocardiographic population of patients aged > 55 years
6 months
The diagnostic accuracy of echocardiographic red flags of Amyloid Cardiomyopathy
Time Frame: 6 months

At the end of phase 2 of this study, patients with Amyloid Cardiomyopathy will be diagnosed, thus allowing to measure the diagnostic accuracy of the following echocardiographic red flags of Amyloid Cardiomyopathy:

  • Restrictive filling pattern (E wave deceleration time <120 ms or ≤150 ms in presence of E/A ≥2) and/or E/E'≥15;
  • "Granular sparkling" appearance of the myocardium;
  • Pericardial effusion of any entity;
  • Interatrial septum thickness >0.5 cm measured in subcostal or four-chamber view;
  • Thickening of the atrio-ventricular (AV) valves (leaflets thickness >0.5 cm);
  • Left ventricular "apical sparing" pattern at speckle-tracking echocardiography.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Multiparametric echocardiographic score
Time Frame: 6 months
Multiparametric echocardiographic score to predict the presence of Amyloid Cardiomyopathy
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Trieste

Collaborators

Pfizer

Investigators

  • Study Chair: Gianfranco Sinagra, MD, Full Professor, Azienda Sanitaria Universitaria Giuliano-Isontina (ASUGI) and University of Trieste
  • Study Chair: Claudio Rapezzi, MD, Full Professor, Cardiology Unit, Azienda Ospedaliero Universitaria di Ferrara - Ferrara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2020

Primary Completion (ACTUAL)

January 20, 2021

Study Completion (ANTICIPATED)

July 25, 2021

Study Registration Dates

First Submitted

January 28, 2021

First Submitted That Met QC Criteria

February 3, 2021

First Posted (ACTUAL)

February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2021

Last Update Submitted That Met QC Criteria

February 3, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199_2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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