RECRUITING

Physio-Anatomy Clinical Data Collection Study

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

This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine.

Official Title

Physio-Anatomy Clinical Data Collection Study

Quick Facts

Study Start:2022-03-14
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05312164

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients \>18 years of age.
  2. * Patients provide written informed consent.
  3. * Clinical presentation consistent with suspected coronary disease.
  4. * Patients who are candidates for PCI and scheduled for coronary diagnostics in the cardiac catheter lab with the intent to perform a physiological assessment for de novo lesions with stenosis, if clinically indicated.
  1. * Presence of acute ST Elevation Myocardial Infarction (STEMI) at the time of the cath lab procedure.
  2. * Contraindication for FFR examination or administration of vasodilators.
  3. * Bacteremia or sepsis.
  4. * Major coagulation system abnormalities.
  5. * Severe hemodynamic instability or shock.
  6. * Heart Failure NYHA Class IV.
  7. * Severe valvular heart disease.
  8. * Prior heart transplant.
  9. * Acute renal failure based on diagnostic practice of the treating physician at time of screening.
  10. * Patient is pregnant.
  11. * Patient is currently enrolled in another clinical study that may impact the results of this study.
  12. * Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit their

Contacts and Locations

Study Contact

Arjun Bhat, MD, MBA
CONTACT
978-202-4108
abhat@gentuity.com

Study Locations (Sites)

Veteran's Administration Palo Alto
Palo Alto, California, 94304
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
Atlanta VA Medical Center
Decatur, Georgia, 30033
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Minneapolis VA Medical Center
Minneapolis, Minnesota, 55417
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States

Collaborators and Investigators

Sponsor: Gentuity, LLC

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 Date2022-03-14
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-03-14
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Coronary Stenosis