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Myocardial InfarctionPhase 1NCT02305602

A Study of VentriGel in Post-MI Patients

A Phase 1 study testing VentriGel in people with Myocardial Infarction and Heart Failure, run by Ventrix, Inc. at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the past 3 years and have evidence of left ventricular remodeling. Read more about this study

Who is it for?
Ages 30 to 75 years
What is being tested?
VentriGel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
6 sitesUnited States
Study dates
Sep 2015to Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject is 30-75 years of age
  • The subject must be able to provide informed consent
  • At least 60 days and no more than 3 years will have passed since the first ST elevation myocardial infarction (Index STEMI) at time of VentriGel administration
  • The Index STEMI must meet the following criteria:
  • First time diagnosis of STEMI AND;
  • Meet the STEMI criteria of the American College of Cardiology (ACC)/American Heart Association (AHA) (e.g. ST elevation in at least 2 contiguous leads >0.2 mV in V1, V2 or V3 and/or >0.1mV in at least two other leads), or new left bundle branch block (LBBB)
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  • Evidence of left ventricular remodeling secondary to the myocardial infarction using 2-D echocardiography or cMR;
  • the LVEF must be ≥ 25% and ≤ 45% AND;
  • The left ventricular wall thickness is ≥ 8 mm in target area.
  • Successful percutaneous coronary intervention (PCI) restoring TIMI II of higher flow to infarcted area
  • Negative pregnancy test [serum human chorionic gonadotropin (βhCG)] in women of childbearing potential within 24 hours prior to dosing) or if less than 2 years postmenopausal agree to use of adequate contraception during the study.
  • Must be ambulatory, willing and able to comply with protocol, including follow-up visits
  • Subject must be receiving best medical treatment for their post-MI clinical presentation according to the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines
  • For those subjects indicated for heart failure medical therapy, subjects must be on stable therapy including beta-blockers and angiotensin converting enzyme inhibitors, if tolerated, for at least 45 days prior to therapy delivery

Who cannot join

  • Contraindications to cardiac MR
  • NYHA Functional Classification 4 heart failure within the prior 6 months.
  • Significant coronary artery stenosis that may require percutaneous or surgical revascularization within six months of enrollment, as determined by the principal investigator
  • Left ventricular thrombus, left ventricular aneurysm, subjects with post-infarction pericarditis, or subjects with wall motion abnormalities outside the region of the infarct related artery
  • Frequent, recurrent, sustained (>30 seconds) ventricular tachycardia in 30 days prior to VentriGel administration
  • ECG or 24 hour Holter Monitor with any of the following findings:
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  • Bifascicular block (left bundle branch block or right bundle branch block plus left hemi-block)
  • Higher grade AV block (i.e. 3rd degree)
  • Ventricular tachycardia (>= 5 seconds of VT OR any symptomatic VT)
  • Atrial fibrillation with heart rate greater than 110 bpm.
  • Severe valvular disease (e.g. aortic stenosis of moderate or worse severity, valvular insufficiency requiring surgical repair) or history of heart valve replacement.
  • Known allergy to porcine proteins or prior implantation of a porcine derived medical product including cardiac valves or other ECM products.
  • Etiology of heart failure due to any cause (e.g. hypertrophic cardiomyopathies, restrictive cardiomyopathies, constrictive pericardial disease, amyloidosis, active myocarditis) other than the index MI.
  • Severe peripheral vascular disease that impairs femoral arterial access.
  • Less than 3 years, cancer free, since end of treatment for cancer (with exception of basal cell carcinoma)
  • Alcohol or drug dependency within six months prior to enrollment
  • Cerebrovascular event within the 90 days prior or major surgical procedure or major trauma within the 14 days prior to enrollment
  • Participation, defined as receiving test article, in an experimental clinical study within 30 days prior to administration of VentriGel (i.e. screen failure from other study does not exclude subject)
  • Uncontrolled hypertension defined as systolic blood pressure (SBP) > 180 mmHg and/or or diastolic blood pressure (DBP) >110 mmHg
  • Abnormal laboratory values as defined below performed at screening:
  • Aspartate aminotransferase [AST]/ alanine aminotransferase [ALT] ≥ 3 times upper limit of normal (ULN)
  • Serum creatinine ≥ 2.0 mg/dL
  • Platelet count < 50,000/mm3
  • Hemoglobin < 9.0 g/dL
  • HbA1c > 9.0%
  • PT or aPTT with clinically significant elevations relative to local laboratory norms
  • Any other cardiac or non-cardiac conditions or illness which, in the opinion of the principal investigator, may place subjects at undue risk or compromise the objectives of the study.
  • Institutional interpretation of cMR EF data outside the ≥ 25% and ≤ 45% limits

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Florida

    Gainesville, Florida, 32606

  • Mercy Gilbert Medical Center

    Gilbert, Arizona, 85297

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • University of Utah

    Salt Lake City, Utah, 84132

Other trials in United States

About this study

Official title: A Phase I, Open-label Study of the Effects of Percutaneous Administration of an Extracellular Matrix Hydrogel, VentriGel, Following Myocardial Infarction

This Phase I, open label, study will investigate the effects of VentriGel injection in patients who have experienced a first, large ST elevation myocardial infarction (STEMI) treated by PCI within the past 3 years and have evidence of left ventricular remodeling.

Read the detailed description

Evaluate the safety and feasibility of VentriGel delivered trans-endocardially to subjects with left ventricular ejection fraction (LVEF) 25 to 45% secondary to MI. Secondary endpoints will look at efficacy variables of ESV, EDV, EF, scar mass.

Being tested
VentriGel
Keywords
extracellular matrix
Medical subject headings
Myocardial Infarction, Heart Failure, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VentriGelBiological

    VentriGel will be injected via MyoStar catheter after NOGA mapping

Study groups in NCT02305602
Study groupRoleWhat they receive
Post Myocardial InfarctionExperimentalVentriGel will be injected via a MyoStar catheter after NOGA mapping in the 60 day to 3 year window since the first STEMI myocardial infarction
Receives: Biological: VentriGel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of serious adverse events that occur within 6 months of injection

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2014 (estimated)
  2. Study startSep 2015
  3. Primary completion5 Sep 2018
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02305602
Sponsor's protocol ID
CV-201
Status last verified
Oct 2019
First submitted
26 Nov 2014
Last updated
25 Oct 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VentriGel in people with Myocardial Infarction and Heart Failure, run by Ventrix, Inc. at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of serious adverse events that occur within 6 months of injection (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02305602.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2019; AzTrials last refreshed its copy on 3 Nov 2026.

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