Real-Time Myocardial Perfusion Echocardiography in the ICU

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-009331
    NCT ID: NCT03173716
    Sponsor Protocol Number: 16-009331

About this study

This study is being done to find out if and how much the use of RTMPE improves a provider's confidence in the diagnosis they assign. This is important because the use of RTMPE may decrease the need for any additional invasive testing.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  1. Adults age ≥ 18 years
  2. Located in a designated ICU
  3. TTE ordered by the primary care team
  4. Significant delta in troponin trend
  5. Concern for myocardial ischemia
  6. Women of child-bearing potential must have a clinical negative pregnancy test result
  7. Experienced sonographer available to complete RTMPE portion of the exam
  8. Provider willing to complete the study survey

Exclusion Criteria:

  1. Adults < 18 years
  2. Contraindication to echo contrast administration
  3. Location other than an ICU
  4. No significant delta in troponin trend

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patricia Pellikka, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Patricia Pellikka M.D.

(507)284-8612

.
CLS-20319147

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