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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01294891
Other study ID # IRB00006948
Secondary ID
Status Completed
Phase N/A
First received February 11, 2011
Last updated October 27, 2014
Start date February 2011
Est. completion date October 2014

Study information

Verified date October 2014
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to examine how abnormal blood flow in the small vessels (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (PNH) or sickle cell disease leads to poor functioning of the heart and kidney. To test this question, the investigators will perform imaging tests (contrast ultrasound perfusion imaging) to look at the flow and function of these microvessels and compare this information to heart and kidney function. To further look at this question, patients who have PNH will be studied before and after starting a new drug (Soliris) that decreases damage to blood cells. In patients with sickle cell disease, patients will be studied at baseline (not during a pain crisis) and also during a pain crisis if one develops.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date October 2014
Est. primary completion date October 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Established diagnosis of PNH or SCD Age > 18 years old

Exclusion Criteria:

- Pregnant or lactating women Presence of significant right to left shunting Allergy to ultrasound contrast agent Reactive airways disease Significant peripheral or coronary artery disease

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Imaging
Contrast ultrasound perfusion imaging and complete echocardiography

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microvascular perfusion Myocardial microvascular blood flow (MBF) and capillary blood velocity (CBV) on study day.
Renal MBF on study day
Skeletal muscle MBF and CBV on study day
Myocardial MBF and CBV during hyperemia
Skeletal muscle CBV during hyperemia
1 hour No
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