N/A N=51

Cardiovascular Complications of Sickle Cell Disease

Sickle Cell Disease

Bottom Line

View on ClinicalTrials.gov: NCT01044901 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: MRI Parameter - LVEDVi, mL/cm2 (Measured Using Method of Disks, Controls Serve as Normal Ranges) — 124.0; 78.7 mL/cm2 — p=0.0039

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: MRI, Transthoracic Echocardiography, tonometry, EKG (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Chicago
Primary completion: Feb 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY MRI Parameter - LVEDVi, mL/cm2 (Measured Using Method of Disks, Controls Serve as Normal Ranges)	124.0; 78.7	0.0039 sig
PRIMARY MRI Parameter - LVESVi, mL/cm2 - (Measured Using Method of Disks, Controls Serve as Normal Ranges)	47; 31	<0.0001 sig
PRIMARY MRI Parameter - LV Mass Index, g/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	77.2; 51.6	0.0137 sig
PRIMARY MRI Parameter - RVEDVi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	126.4; 83.0	0.0039 sig
PRIMARY MRI Parameter - RVESVi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	56.3; 37.8	0.16
PRIMARY MRI Parameter - LAi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	64.8; 41.1	0.0039 sig
PRIMARY MRI Parameter - RAi, mL/cm2, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	76; 52	0.0011 sig
PRIMARY MRI Parameter - LVEF, %, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	58; 64	0.10
PRIMARY MRI Parameter - RVEF, %, (Measured Using Method of Disks, Controls Serve as Normal Ranges)	56.1; 55.4	0.48
PRIMARY MRI Parameter - Late Gadolinium Enhancement, Performed Via Visual Inspection, Normally None Should be Present	8; 0	0.08
PRIMARY MRI Parameter - Myocardial T2-star, ms, Performed Using Decay Curves (Normal >20ms)	41.6; 38.4	0.91
PRIMARY MRI Parameter - Hepatic T2-star, ms, Performed Using Decay Curves, Normal >18ms	10; 30	0.0038 sig
PRIMARY MRI Parameter - Myocardial Perfusion Reserve Index, Measured Using Upslope Technique. Control Subjects Available for Normal Ranges	1.4; 1.87	0.034 sig
PRIMARY MRI Parameter - Diastolic Dysfunction, Determined According to American Society of Echocardiography Guidelines	10; 1	0.25
PRIMARY MRI Parameter - Lateral E/e', Measured Using Doppler Echo. Controls Available as Normal Ranges	7.2; 6.0	0.0288 sig
PRIMARY MRI Parameter - Augmentation Pressure, See Controls for Normal Ranges	9.0; 2.0	0.14
PRIMARY MRI Parameter - Augmentation Index, See Control Subjects for Normal Ranges	23.6; 12.5	0.13
PRIMARY MRI Parameter - Systemic Systolic Blood Pressure	122.3; 132	0.81
PRIMARY MRI Parameter - Systemic Diastolic Blood Pressure, mm Hg	68.3; 74.9	0.30
SECONDARY Genome-Wide Gene Expression and Targeted Genetic Polymorphisms in SCD Patients Linked to a Quantitative Noninvasive-based PH Phenotype.	—	—

Summary

In this research study, we are using heart imaging exams and blood testing, in order to gain an improved understanding of the pulmonary (lung) hypertension and cardiovascular (heart) complications that often occur in sickle cell patients. Information gathered from the healthy volunteers that participate in this study will be compared to information from the sickle cell patients in this study in order to help further our understanding.

Eligibility Criteria

Inclusion Criteria

Patients must be 18+
Patients who were diagnosed with SCD confirmed by high-pressure liquid chromatography or hemoglobin electrophoresis will be eligible for the study
Only patients in stable condition will be included
Patients receiving transfusions will not be excluded

Exclusion Criteria

Patients with vaso-occlusive crises or an episode of acute chest syndrome within the previous four weeks (after 4 weeks have passed, the patients may be re-evaluated for eligibility)
Patients with high degree heart block; active, hemodynamically significant, ventricular arrhythmias; unstable coronary syndromes; history of myocardial infarction within 1 month of the study.
Contraindications to gadolinium-enhanced magnetic resonance examination such as severe claustrophobia, Pacemaker, defibrillators, cerebral aneurysm clips, or neurostimulator.
Pregnancy
Patients with sinus node dysfunction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01044901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.