Assessment of Coronary Plaque Composition Using Optical Coherence Tomography

  • Study type:

    Interventional What is this?

    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.

Study IDs

  • Site IRB:

    • Rochester, Minnesota: 10-005460
  • NCT ID:

    NCT01642173
  • Sponsor Protocol Number:

    10-005460

About this study

The investigators hypothesis is that local activation of the endogenous Lp-PLA2 plays an integral role in early atherosclerosis, and contributes to the mechanism of coronary endothelial dysfunction and to the structural and mechanical properties that characterize plaque vulnerability. Thus, the investigators study will characterize prospectively the correlation between the functional and structural vascular wall properties, and the activity of the Lp-PLA2 pathway.

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:

  • age > 18 years and < 85 years
  • referred to our cardiac catheterization laboratory for coronary vasomotion testing
  • are found to have coronary endothelial dysfunction.

Exclusion Criteria:

  • these include heart failure
  • ejection fraction < 40%
  • unstable angina
  • myocardial infarction or angioplasty within 6 months prior to entry into the study
  • use of investigational agents within 1 month of entry into the study,
  • patients who require treatment with positive inotropic agents other than digoxin during the study
  • patients with cerebrovascular accident within 6 months prior to entry the study
  • significant endocrine, hepatic or renal, disorders
  • local or systemic infectious disease within 4 weeks prior to entry into study
  • pregnancy or lactation
  • mental instability
  • Federal Medical Center inmates

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Gulati, M.D., Ph.D.

Contact us for the latest status

Cindy Woltman R.N.

(507)266-4095

Woltman.Cindy@mayo.edu