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(352) 733-0111

Cardiamp CMI

  • Status
    Accepting Candidates
  • Age
    21 Years - 80 Years
  • Sexes
    All
  • Healthy Volunteers
    No
I'm interested
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Objective

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment

Treatment Group:

Subjects treated with aBMC using the CardiAMP cell therapy system

Sham Control Group:

Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

Details

Full study title Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with refractory chronic myocardial ischemia (CardiAMP CMI Trial)
Protocol number OCR33982
ClinicalTrials.gov ID NCT03455725
Phase N/A

Eligibility

Inclusion Criteria:

  1. Male or female 21 to 80 years of age

  2. Canadian Cardiovascular Society (CCS) class III or IV chronic refractory angina.

  3. Lack of control of angina symptoms despite maximum tolerated doses of anti-angina drugs.

  4. Evidence of inducible myocardial ischemia on baseline stress testing

  5. Obstructive coronary disease unsuitable for conventional revascularization

  6. Experience angina episodes at a minimum of 7 angina episodes per week (during a 4-week screening period).

  7. Able to complete an exercise tolerance test on the treadmill

  8. Left ventricular ejection fraction of greater than or equal to 40% as measured by echocardiography.

  9. Qualification of a pre-procedure screening of bone-marrow aspiration

Exclusion Criteria

Other cardiac or vascular system or other health-related criteria which may be seen in a

patient's history and physical examination.

Lead researcher

  • R. David Anderson, MD, MS, FACC, FSCAI
    Cardiologist (Heart Specialist), Interventional Cardiologist, Internist
    R. David Anderson

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  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.