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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Trieste

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 20, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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