Targeting Pulmonary Perfusion in Alpha-1 Antitrypsin Deficiency
Completed · Phase 2 · Has a placebo group
Conditions studied: Alpha-1 Antitrypsin Deficiency, Emphysema, Chronic Obstructive Pulmonary Disease
In brief
The aim of this study is to test whether aspirin improves endothelial function in alpha-1 antitrypsin deficiency-associated lung disease, measured by pulmonary microvascular blood flow on magnetic resonance imaging (MRI) and with apoptotic endothelial microparticles.
Key facts
- Study ID
- NCT03008915
- Run by
- Columbia University
- People needed
- 15
- Starts
- 2017-01-01
- Expected to finish
- 2020-10-01
- Last updated by the study team
- 2021-02-17
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Alpha-1 antitrypsin deficiency (PiZZ genotype)
- 40 years of age or older
- Evidence of emphysema on CT scan as read by a Radiologist
You may not qualify if…
- Platelet count < 150,000/dL, history of intracranial hemorrhage or severe GI bleed, use of systemic anticoagulant, physician prescribed use of antiplatelet drug (including aspirin and P2Y12 receptor inhibitors), or known severe liver disease
- Immunosuppression by use of medications (including oral prednisone), or those with immunomodulatory disease (organ transplantation, autoimmune conditions or actively-treated malignancy)
- Known atrial fibrillation or left ventricular (LV) systolic heart failure
- Contraindication to MRI, including pregnancy, weight > 300 lbs (due to weight limits of the machine), those with pacemakers, aneurysm clips, cochlear implants or other implanted electronic devices, or severe claustrophobia;
- Chronic renal insufficiency (estimated GFR < 45 L/min/1.73 m2 or self report) due to slightly increased risk of nephrogenic systemic fibrosis from gadolinium administration and aspirin-related renal insufficiency
- Exacerbation of respiratory symptoms within the previous 6 weeks, such as that requiring hospitalization, oral prednisone or antibiotics to control symptoms.
Where it is running
- Columbia University — New York, New York, United States
Full record on ClinicalTrials.gov
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