Myocardial Injury Clinical Trial
Official title:
Myocardial Perfusion and Fibrosis in Cancer Survivors
NCT number | NCT03191461 |
Other study ID # | HM20015409 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | November 13, 2017 |
Est. completion date | July 31, 2024 |
This is a cross-sectional pilot study. The investigators seek to obtain early information pertaining to the relationship between measurements of myocardial perfusion reserve and myocardial fibrosis after receipt of Anthracycline-based chemotherapy (≥2 years prior).
Status | Recruiting |
Enrollment | 28 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 85 Years |
Eligibility | Inclusion Criteria : 1. Cancer patients must have Stage I-III breast cancer or lymphoma and have received an anthracycline agent during treatment at least 2 years prior to enrollment in this study. 2. Age-matched to cancer survivor with no history of cancer or anthracycline treatment. 3. Age 21-85 years of age at the time of enrollment. 4. ECOG or Karnofsky performance status of 0-1. 5. Life expectancy of greater than 3 months. 6. Enrolled control participants must have normal creatinine clearance of >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 7. Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria : 1. History of allergic reactions attributed to compounds of similar chemical or biologic composition to gadolinium contrast agents or adenosine or history of kidney disease. 2. Those with contraindications for MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices. 3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Pregnant women are excluded from this study because the use of gadolinium in cardiac MRI imaging may not be safe in pregnant women. Because some methods of birth control are not 100% reliable, a pregnancy test is required if the participant is a) a sexually active woman of childbearing potential or b) a sexually active peri or post-menopausal women whose last normal menstrual period was less than 12 months ago. 5. Coronary revascularization in the past 6 months or known severe multi-vessel CAD previously determined to be not amendable to mechanical intervention. 6. Ongoing, unrelieved symptoms thought to represent cardiac ischemia and requiring immediate cardiac catheterization 7. History of COPD or asthma |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Wake Forest Baptist Heath | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University | Wake Forest University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Myocardial perfusion reserve index (MPRI) | The myocardial perfusion reserve index (MPRI) will be measured noninvasively with adenosine stress CMR imaging after dual-bolus first-pass perfusion with gadolinium contrast. The slope of the myocardial signal intensity curve is computed and normalized by the slope of the blood pool signal intensity curve for both rest and stress. MPRI is calculated as the ratio of the stress slope divided by the rest slope. | During Adenosine Stress Test | |
Secondary | Myocardial fibrosis quantification using Myocardial T1 | Measured noninvasively with CMR imaging. For myocardial fibrosis quantification with T1 endocardial and epicardial contours are drawn to delineate the myocardium; mean T1 (pre- and post-contrast) is calculated from the pixels within the myocardium. Expected range of T1 is 900-1250ms with higher T1 values considered a worsened outcome. | During Adenosine Stress Test | |
Secondary | Myocardial fibrosis quantification using extracellular volume (ECV) | Measured noninvasively with CMR imaging. The ECV is calculated from the mean myocardial T1 and LV blood T1 pre- and post-contrast. Expected range of ECV is 20-40% with higher ECV values representing a worse outcome. | During Adenosine Stress Test |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
Completed |
NCT01688648 -
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft
|
N/A | |
Completed |
NCT04794062 -
Myocardial Injury and Quality of Life After COVID-19
|
||
Recruiting |
NCT04750616 -
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
|
Phase 2 | |
Recruiting |
NCT04615871 -
Semaglutide to Reduce Myocardial Injury in PATIents With COVID-19
|
Phase 2 | |
Withdrawn |
NCT04139655 -
Colchicine Prevents Myocardial Injury After Non-Cardiac Surgery Pilot Study
|
N/A | |
Completed |
NCT05691764 -
Effect of Cyclosporine and Remote Ischemic Preconditioning in Reperfusion Ischemia Injury on Tetralogy Fallot Patients With Correction Surgery
|
N/A | |
Completed |
NCT04436016 -
PeRiOperaTivE CardioproTection With Ivabradine in Non-cardiac Surgery
|
Phase 4 | |
Completed |
NCT05748691 -
Switching From Cardiac Troponin I to T
|
||
Completed |
NCT03338504 -
Determining the Mechanism of Myocardial Injury and Role of Coronary Disease in Type 2 Myocardial Infarction
|
||
Recruiting |
NCT03013634 -
Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation
|
N/A | |
Completed |
NCT00007358 -
Dexamethasone Treatment for Congenital Heart Block (CHB) in Newborns With Lupus
|
N/A | |
Recruiting |
NCT05714618 -
MR Evidence of Cardiac Inflammation Post-Stroke
|
||
Recruiting |
NCT04624503 -
Prognostic and Clinical Impact of Cardiovascular Involvement in Patients With COVID-19
|
||
Active, not recruiting |
NCT03339180 -
Cardiac Injury in Patients With Influenza
|
||
Completed |
NCT03010839 -
Cardiopulmonary Protective Effects of Modified Remote Ischaemic Preconditioning in Mitral Valve Replacement Surgery
|
N/A | |
Recruiting |
NCT04743765 -
HIP Fracture Accelerated Surgical TreaTment And Care tracK 2 Trial
|
N/A | |
Enrolling by invitation |
NCT03253835 -
Cardiac Blood Flow Patterns Associated With Left Ventricular Myocardial Damage
|
||
Completed |
NCT00817791 -
Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery
|
N/A | |
Completed |
NCT04149314 -
The "Hypotension Prediction Index" in Patients Undergoing Lung Surgery
|
N/A |