Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disea… (NCT05583721) | Clinical Trial Compass
RecruitingPhase 2
Relationship Between Abnormal Myocardial Perfusion and Diastolic Dysfunction in Sickle Cell Disease Using PET
United States40 participantsStarted 2023-10-10
Plain-language summary
There is limited information on what causes injury to the heart in individuals with Sickle Cell Disease (SCD). Researchers in this study want to see if decreased blood flow to the heart during stress could be causing the heart damage seen in SCD patients. They also want to test people who don't have SCD to see if their hearts react the same way under stress.
Primary Objective
* To estimate the coronary flow reserve (CFR) (also referred to as myocardial perfusion reserve), as measured by PET stress-rest myocardial perfusion imaging, in SCD patients with and without diastolic dysfunction, and healthy controls.
Secondary Objectives
* To investigate the relationship between decreased CFR (quantified with PET stress- rest myocardial perfusion imaging) and presence of abnormal diastolic parameters
Who can participate
Age range
18 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria - Stratum A: Sickle cell patients with diastolic dysfunction
* 18 to 21 years of age
* Black
* Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
* Three or more abnormal diastolic parameters (based on guidelines by American Society of echocardiography)
Inclusion Criteria - Stratum B: Sickle cell patients without diastolic dysfunction
* 18 to 21 years of age
* Black
* Diagnosis of SCD of HbSS and HbSβ0thalassemia genotypes
* Two or less abnormal diastolic parameters
Inclusion Criteria - Stratum C: Healthy controls
* 18 to 21 years of age
* Black
* Two or less abnormal diastolic parameters
Exclusion Criteria - Stratum A:
* Recent hospitalization for vaso-occlusive pain crisis or acute chest syndrome in last 4 weeks
* Blood transfusion in the last 3 months
* Individuals with signs, symptoms or EKG findings of acute myocardial ischemia, infarction or unstable angina
* Individuals with history of VT/VF or SVT
* Previous cardiac surgery
* Known congenital heart disease (other than patent ductus arteriosus or Atrial septal defect)
* Stenotic valvular disease or left main coronary artery stenosis
* History of myo/pericarditis
* Left ventricle systolic dysfunction
* Cardiovascular instability/uncontrolled hypertension (h/o hypertensive urgency or emergency)
* History of sinus node dysfunction or high grade AV nodal block
* History of aborted sudden cardiac death or cardiac arrest
* Current seizure disorder on AED
* Pregnant/Breast-feeding
* Any medical …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean and standard deviation of coronary flow reserve (CFR)
Timeframe: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)
2
CFR difference among Stratum A, Stratum B, and Stratum C
Timeframe: Visit 2, approximately 4 weeks after study entry (procedure takes approximately one hour)