Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— VCU-Alpha1RT  

Official title:

Alpha-1 Anti-Trypsin (AAT) to Quench the Acute Inflammatory Response in ST-segment Elevation Acute Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936896
• Other study ID #: HM15342
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 30, 2013
• Last updated: January 15, 2016
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: January 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: IRB Panel D, Virginia Commonwealth University
• Study type: Interventional

Clinical Trial Summary

Acute myocardial infarction is characterized by an intense inflammatory response.

The degree of the response influences clinical outcome, with 'more' inflammation promoting heart failure. In this study we plan to determine whether treatment with plasma derived alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment elevation myocardial infarction (STEMI).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• Acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and ECG evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new

• Planned or completed coronary angiogram for potential intervention

• Age>21

Exclusion Criteria:

• Inability to give informed consent

• Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump)

• Pregnancy

• Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV)

• Preexisting severe left ventricular dysfunction (EF<20%)

• Preexisting severe valvular heart disease

• Known active infections (acute or chronic)

• Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only)

• Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus)

• Known active malignancy of any type, or prior diagnosis in the past 10 years

• Anticipated need for cardiac or major surgery

• Known active cancer (or prior diagnosis of cancer within the past 10 years)

• Known Immunoglobulin A (IgA) deficiency

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Alpha 1-Antitrypsin

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	We will record the number of participants with all adverse events (cardiac and non-cardiac) over the 3 months, including infusion reactions and drug-related issues.	3 months	Yes
Primary	C Reactive Protein (Area Under the Curve)	A single area under the curve (AUC) calculation based upon C-reactive protein (CRP) values drawn at baseline, 3 days, and 14 days.	14 days	No
Secondary	Left Ventricular End-systolic Volume Change	We will calculate the interval change between admission and 3 months in left ventricular end-systolic volume, using echocardiography	3 months	No