NCT01539590

Brief Summary

The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function following myocardial infarction (heart attack).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

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

February 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 27, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 4, 2014

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2014

Enrollment Period

1 year

First QC Date

February 22, 2012

Results QC Date

October 29, 2014

Last Update Submit

November 7, 2014

Conditions

Myocardial Infarction

Keywords

hepatocyte growth factor mimetichepatocyte growth factor(HGF)Myocardial InfarctionAcute ST Segment Elevation Myocardial Infarction (STEMI)Percutaneous Coronary Intervention (PCI)

Outcome Measures

Primary Outcomes (2)

  • Evaluation of Reduction in Infarct Size

    Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage

    6 month

  • Evaluation of the Degree of Late Ventricular Remodeling

    Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).

    6 months

Secondary Outcomes (18)

  • Change in CK-MB and Troponin

    6 months

  • Change in BNP Levels

    6 months

  • Change in Symptoms and Clinical Signs of CHF

    6 months

  • Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)

    6 months

  • LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography

    6 months

  • +13 more secondary outcomes

Study Arms (2)

BB3

EXPERIMENTAL

Daily intravenous administration of 2 mg/kg BB3 for four (4) days

Drug: BB3

Normal Saline

PLACEBO COMPARATOR

Daily intravenous administration for four (4) days

Drug: Normal saline

Interventions

BB3DRUG

Daily intravenous administration of 2 mg/kg BB3 for four (4) days

BB3
Normal salineDRUG

Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.

Normal Saline

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided and signed written informed consent, approved by the Institutional Review Board (IRB), prior to performance of any study related procedure including screening procedure.
  • Subject is male or female
  • Subject is 21 to 80 years of age
  • Estimated body weight \< 120 kg and BMI \< 40
  • Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) (e.g., chest pain, arm pain, etc.,) \>30 minutes duration and unresponsive to nitroglycerin; with ST segment elevation of more than 1 mm in at least two contiguous leads of ECG or new or presumed new onset bundle branch block (BBB)
  • Fulfills clinical center's criteria for primary PCI
  • PCI will be done within 12 hours of onset of STEMI.
  • The subject and his/her physician are willing to comply with the requirements of the study and the specified follow-up evaluations.
  • If female, either surgically sterile or post-menopausal or using acceptable contraception and agree to use effective birth control regimen during the study period. Men must agree to use condoms during the study period. Women of child bearing potential must have a negative urine or serum pregnancy test.
  • In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.

You may not qualify if:

  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 6 months following index procedure.
  • Cardiogenic shock (Killip class 4) or cardiac arrest
  • History of prior myocardial infarction or pre-existing Q waves on ECG
  • An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first six months post enrollment;
  • Cardiac pacemaker or implantable defibrillator;
  • Non-MRI-compatible aneurysm clip;
  • Neural stimulator (e.g., TENS-Unit);
  • Any implanted or magnetically activated device (e.g., insulin pump);
  • Any type of non-MRI-compatible metallic ear implant;
  • Metal shavings in the orbits;
  • Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
  • Any history indicating contraindication to MRI, including claustrophobia or allergy to gadolinium;
  • Inability to follow breathhold instructions or to maintain a breathhold for \>15 seconds;
  • Irregular cardiac rhythm not expected to resolve after treatment of the acute cardiac condition (e.g., chronic atrial fibrillation)
  • Known hypersensitivity or contraindication to gadolinium contrast.
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55417-1139, United States

Location

Yale University Medical Center

New Haven, New York, 06520, United States

Location

MeSH Terms

Conditions

Myocardial InfarctionDeafness, Autosomal Recessive 39ST Elevation Myocardial Infarction

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

Five subjects were enrolled into the study; 3 subjects were randomized to BB3 and 2 subjects to placebo. All the 3 subjects randomized to BB3 discontinued the study prematurely. The 2 subjects randomized to placebo completed study treatment.

Results Point of Contact

Title
Dr. Joesph Brennan
Organization
Yale University Medical Center
Brennan.Joesph@yale.edu
(203) 483-8300

Study Officials

  • Weizhong Cai

    Sponsor GmbH

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2012

First Posted

February 27, 2012

Study Start

July 1, 2012

Primary Completion

July 1, 2013

Study Completion

November 1, 2013

Last Updated

November 21, 2014

Results First Posted

November 4, 2014

Record last verified: 2014-11

Locations

US(2)