RECRUITING

Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.

Conditions

Atrial Fibrillation Atrial Myopathy Cardiovascular Risk Factors Heart Murmurs Arrhythmias Cardiac Disease

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.

Official Title

Tulane iPredict, Prevent (TiPP) Study

Quick Facts

Study Start:2025-04-08

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04703166

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.

Ages Eligible for Study:18 Years to 79 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participants with atrial fibrillation aged 18 to 79 years old, or * Participants aged 40 to 79 years old, at moderate or high risk for CVD as defined by the 10-year risk Atherosclerotic Cardiovascular Disease (ASCVD), a validated risk calculation tool. * Participants who have access to internet/e-mail in their homes. * Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer). * Participants who are able and willing to return to the study clinic one-year following their baseline CMR for a follow-up appointment and 12-month CMR. * Participants who are able to read, understand, and sign the consent form.	* Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.). * Participants weighing \>300 lbs. (MRI quality decreases as BMI increases). * Participants with renal insufficiency (Glomerular Filtration Rate (GFR) \<30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease. * Women who are pregnant at the time of enrollment/consent. (Should a participant become pregnant during the course of the study, no CMR will be performed until 10 days, postpartum). * Participants who do not have access to the internet/e-mail. * Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer). * Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices. * Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR. * Participants with cognitive impairments who are unable to give informed consent.

Inclusion Criteria

Exclusion Criteria

* Participants with atrial fibrillation aged 18 to 79 years old, or
* Participants aged 40 to 79 years old, at moderate or high risk for CVD as defined by the 10-year risk Atherosclerotic Cardiovascular Disease (ASCVD), a validated risk calculation tool.
* Participants who have access to internet/e-mail in their homes.
* Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
* Participants who are able and willing to return to the study clinic one-year following their baseline CMR for a follow-up appointment and 12-month CMR.
* Participants who are able to read, understand, and sign the consent form.

* Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.).
* Participants weighing \>300 lbs. (MRI quality decreases as BMI increases).
* Participants with renal insufficiency (Glomerular Filtration Rate (GFR) \<30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease.
* Women who are pregnant at the time of enrollment/consent. (Should a participant become pregnant during the course of the study, no CMR will be performed until 10 days, postpartum).
* Participants who do not have access to the internet/e-mail.
* Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
* Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
* Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR.
* Participants with cognitive impairments who are unable to give informed consent.

Contacts and Locations

Study Contact

Quintrele Jones, MPH

CONTACT

504-988-3063

qjones1@tulane.edu

Chris Wang, MS

CONTACT

504-988-3065

hwang37@tulane.edu

Principal Investigator

Nassir F Marrouche, MD

PRINCIPAL_INVESTIGATOR

Tulane University School of Medicine

Study Locations (Sites)

Tulane University School of Medicine

New Orleans, Louisiana, 70112

United States

Collaborators and Investigators

Sponsor: Tulane University School of Medicine

Nassir F Marrouche, MD, PRINCIPAL_INVESTIGATOR, Tulane University School of Medicine

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 Registration Dates

Study Start Date2025-04-08

Study Completion Date2027-12

Study Record Updates

Study Start Date2025-04-08

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Atrial Fibrillation
Atrial Myopathy
Cardiovascular Risk Factors
Heart Murmurs
Arrhythmias
Cardiac Disease

Additional Relevant MeSH Terms

Atrial Fibrillation