NCT01936896

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 6, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 12, 2016

Completed
Last Updated

February 12, 2016

Status Verified

January 1, 2016

Enrollment Period

6 months

First QC Date

August 30, 2013

Results QC Date

December 10, 2015

Last Update Submit

January 15, 2016

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionHeart FailureInflammation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Left Ventricular End-systolic Volume Change

    3 months

Other Outcomes (1)

  • Safety

    3 months

Study Arms (1)

Alpha-1 anti-trypsin (AAT)

EXPERIMENTAL

We will use plasma derived AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)

Drug: Alpha 1-Antitrypsin

Interventions

Alpha 1-AntitrypsinDRUG
Also known as: Prolastin C, Aralast NP
Alpha-1 anti-trypsin (AAT)

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Abouzaki NA, Christopher S, Trankle C, Van Tassell BW, Carbone S, Mauro AG, Buckley L, Toldo S, Abbate A. Inhibiting the Inflammatory Injury After Myocardial Ischemia Reperfusion With Plasma-Derived Alpha-1 Antitrypsin: A Post Hoc Analysis of the VCU-alpha1RT Study. J Cardiovasc Pharmacol. 2018 Jun;71(6):375-379. doi: 10.1097/FJC.0000000000000583.

    PMID: 29634656DERIVED

MeSH Terms

Conditions

Heart FailureInflammation

Interventions

alpha 1-Antitrypsin

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesSerpinsPeptidesAmino Acids, Peptides, and ProteinsAcute-Phase ProteinsBlood ProteinsProteinsAlpha-GlobulinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Antonio Abbate
Organization
Virginia Commonwealth University
antonio.abbate@vcuhealth.org
8048280513

Study Officials

  • Antonio Abbate, MD, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

  • Benjamin Van Tassell, PharmD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 6, 2013

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

July 1, 2014

Last Updated

February 12, 2016

Results First Posted

February 12, 2016

Record last verified: 2016-01

Locations

US(1)