Cardiovascular Complications of Sickle Cell Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University of Chicago.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Amit Patel, University of Chicago
ClinicalTrials.gov Identifier:
NCT01044901
First received: January 6, 2010
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Sickle Cell Disease
Procedure: MRI, Transthoracic Echocardiography, tonometry, EKG

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cardiovascular Complications of Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • We plan to comprehensively and quantitatively characterize the cardiopulmonary complications of SCD and gain an improved understanding of the pathophysiology of pulmonary hypertension and diastolic dysfunction in patients with Sickle Cell Disease. [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To detect genome-wide gene expression and targeted genetic polymorphisms in SCD patients linked to a quantitative noninvasive-based PH phenotype. [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

We will study blood samples for chemicals related to sickle cell and heart and lung disease, and will be evaluating DNA for purposes of the study.


Estimated Enrollment: 220
Study Start Date: March 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects with Sickle Cell Disease Procedure: MRI, Transthoracic Echocardiography, tonometry, EKG
Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
Other Names:
  • electrocardiography
  • Cardiac magnetic resonance
  • Doppler trans-thoracic echocardiography
Healthy Volunteers Procedure: MRI, Transthoracic Echocardiography, tonometry, EKG
Unless contraindicated, subjects will receive Regadenoson and Gadolinium contrast agent during the Cardiac magnetic resonance. The tonometer, EKG, and echo are non-invasive procedures.
Other Names:
  • electrocardiography
  • Cardiac magnetic resonance
  • Doppler trans-thoracic echocardiography

Detailed Description:

Cardiac magnetic resonance (CMR) has gained increasing clinical application in cardiopulmonary diseases. Due to its 3-dimensional nature, CMR is considered the gold-standard for quantifying left and right ventricular systolic function and size. Additionally, its high tissue contrast allows for a detailed characterization of myocardial tissue. Specifically, the use of techniques such as late gadolinium enhancement can be used to detect the presence of tiny amounts of myocardial scar. Other techniques have been shown to correlate strongly with myocardial iron content. Just as importantly, CMR perfusion imaging can accurately quantify myocardial blood flow and can provide tremendous insight into the function of the microcirculation. CMR's high spatial and temporal resolution, its 3-dimensional approach, its ability to characterize the tissue, and its ability to evaluate the micro- and macro-circulation make it a comprehensive technique for the evaluation of heart disease. Recently, one CMR study has already shown the presence of cardiac microvascular disease in a subset of adult sickle cell disease (SCD) patients in the absence of infarcted myocardium, myocardial iron overload, or coronary artery disease, increasing the evidence for the contribution of left heart disease to pulmonary hypertension (PH) development in these patients; unfortunately, strong conclusions could not be made because the study was underpowered. Thus, this proposal will leverage the advantages offered by CMR to better characterize and detect the PH and cardiopulmonary subphenotypes in the SCD patient population.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects will be recruited from clinics at the University of Chicago as well as from the community via flyers posted at the University of Chicago and a web site posted on the University of Chicago Medical Center web site.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044901

Contacts
Contact: Amit R Patel, M.D. 773-702-1843 amitpatel@uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60430
Contact: Amit R Patel, M.D.    (773) 702-1843    amitpatel@uchicago.edu   
Principal Investigator: Amit R Patel, M.D.         
Sub-Investigator: Joe G.N. Garcia, M.D.         
Sub-Investigator: Roberto M Lang, M.D.         
Sub-Investigator: Nicole Artz, M.D.         
Sub-Investigator: Roberto Machado, M.D.         
Sub-Investigator: Ankit A Desai, M.D.         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Amit R Patel, M.D. University of Chicago
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amit Patel, Asst Prof of Medicine, University of Chicago
ClinicalTrials.gov Identifier: NCT01044901     History of Changes
Other Study ID Numbers: 16653A
Study First Received: January 6, 2010
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Sickle Cell Disease
Cardiac magnetic resonance imaging
Coronary Disease
Pulmonary Hypertension

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on July 28, 2014