RECRUITING

Mechanistic Clinical Trial of Advanced Imaging for CRT

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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 a mechanistic clinical trial with randomization to guidance for the CRT procedure using cardiac magnetic resonance (CMR) and computed tomography angiography (CTA) versus a standard procedure.

Official Title

Advanced Imaging and Inflammatory Markers to Define Mechanisms of Response to CRT

Quick Facts

Study Start:2018-01-05

Study Completion:2025-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03398369

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:20 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Chronic systolic HF 2. LVEF 35% or less 3. Guideline-based class I or II indication for CRT	1. Inability to provide informed consent 2. Pregnancy 3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging 4. Cerebral aneurysm clips 5. Cochlear implants 6. Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs) 7. Severe claustrophobia 8. Acute kidney injury 9. Acute renal failure or chronic kidney disease with GFR \< 45 cc/min/1.73m2 10. Liver transplant 11. Gadolinium allergy 12. \>10% premature ventricular contraction (PVC) burden; and 13) estimated \>10% atrial fibrillation (AF) burden based on available clinical data.

Inclusion Criteria

Exclusion Criteria

1. Chronic systolic HF
2. LVEF 35% or less
3. Guideline-based class I or II indication for CRT

1. Inability to provide informed consent
2. Pregnancy
3. Presence of metal embedded in the body due to prior accident or injury, as documented by skull films or other imaging
4. Cerebral aneurysm clips
5. Cochlear implants
6. Other metallic implants known to be contraindications to CMR (does not include pacemakers and ICDs)
7. Severe claustrophobia
8. Acute kidney injury
9. Acute renal failure or chronic kidney disease with GFR \< 45 cc/min/1.73m2
10. Liver transplant
11. Gadolinium allergy
12. \>10% premature ventricular contraction (PVC) burden; and 13) estimated \>10% atrial fibrillation (AF) burden based on available clinical data.

Contacts and Locations

Study Contact

Kenneth C Bilchick, MD

CONTACT

4349242465

bilchick@virginia.edu

Hollis Phillips, BA

CONTACT

434-243-0046

hp9r@hscmail.mcc.virginia.edu

Principal Investigator

Kenneth C Bilchick, MD

PRINCIPAL_INVESTIGATOR

University of Virginia Health System

Study Locations (Sites)

University of Virginia Health System

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of Virginia

Kenneth C Bilchick, MD, PRINCIPAL_INVESTIGATOR, University of Virginia Health System

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 Date2018-01-05

Study Completion Date2025-01-15

Study Record Updates

Study Start Date2018-01-05

Study Completion Date2025-01-15

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure, Systolic