Clinical trial · Interventional
Computed Tomography and Biomarker Analysis in Diagnosing Coronary Artery Disease in Asymptomatic Patients Who Have Undergone Stem Cell Transplant
Assessment of Coronary Artery Disease in Asymptomatic Survivors of Allogeneic Hematopoietic Cell Transplantation (HCT): A Pilot Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This pilot clinical trial studies computed tomography (CT) scans and biomarker analysis in diagnosing coronary artery disease (CAD) in patients who have undergone a stem cell transplant but have no symptoms of CAD. CAD is a disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart) and patients who have undergone a stem cell transplant are at an especially high risk for CAD. A CT scan involves a series of detailed pictures of areas inside the body taken from different angles. The pictures are created by a computer linked to an x-ray machine. Studying samples of blood from patients who have undergone a stem cell transplant in the laboratory may help doctors identify and learn more about biomarkers related to CAD. Using a CT scan in combination with biomarker analysis may be a better and less-invasive way to diagnose CAD.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Survivor | — | UNRESOLVED | — |
| Diabetes Mellitus | — | UNRESOLVED | — |
| Hypertension | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (CT and blood biomarkers)
- description
- Patients undergo cardiac CT and collection of blood samples for analysis of hs-CRP via quantitative immunoturbidimetry and Lp-PLA2 via ELISA.
- interventionNames
- Procedure: computed tomography
- Other: cytology specimen collection procedure
- Other: laboratory biomarker analysis
- Other: questionnaire administration
Primary outcomes (1)
- measure
- Feasibility, defined by the percentage of patients that enroll onto the study, successful completion of all study measurements, ability of studies to be interpreted, and achievement of the recruitment goal
- timeFrame
- Up to 9 weeks
- description
- The current protocol will be considered feasible if: 1) \>= 30% of eligible patients that are approached for participation enroll onto the study, 2) \>= 75% enrolled participants successfully complete all study measurements (history/physical examination, blood draw, completion of study questionnaires, CT-imaging), 3) \>= 90% of CT-based studies can be interpreted and 4) =\< 100 individuals are approached to achieve recruitment goal of 20 participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Alive and in complete remission at time of enrollment * Underwent allogeneic HCT after 1995 * Time between HCT and study entry: \>= 2 years * Have at least one CVRF (hypertension, diabetes, dyslipidemia) at the time of eligibility determination Exclusion Criteria: * History of ischemic heart disease, stroke, or cardiomyopathy/congestive heart failure * Abnormal renal function (glomerular filtration rate \[GFR\] \< 60 mL/min/1.73m2) * Pregnancy * Known allergy to intravenous (IV) contrast * Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrioventricular block or sick sinus syndrome) * Current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy * History of drug sensitivity or allergic reaction to beta-blockers * Currently taking calcium channel blockers such as verapramil and diltiazem * History of unrepaired severe aortic stenosis
References
Publications (0)
Data not yet available