A Study to Evaluate Ischemia in Women to Reduce Non-obstructive CAD Events

Overview

About this study

The purpose of this trial is to determine whether aggressive medication treatment to modify risk factors in women with coronary arteries showing no severe obstruction but with cardiac symptoms (i.e., chest pain) will reduce their likelihood of dying, having a heart attack, stroke or being hospitalized. 

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Signs and symptoms of suspected ischemia prompting referral for further evaluation by cardiac catheterization, or coronary angiogram or coronary CT angiogram within 5 years from consent.
  • Willing to provide written informed consent.
  • Age ≥ 18 years old.
  • Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR > 0.80.

Exclusion Criteria:

  • History of noncompliance (with medical therapy, protocol, or follow-up).
  • History of non-ischemic dilated or hypertrophic cardiomyopathy.
  • Documented ACS within previous 30 days.
  • LVEF < 40%, NYHA HF class III-IV, or hospitalization for HFrEF within 180 days.
  • Stroke within previous 180 days or intracranial hemorrhage at any time.
  • End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) < 30 ml/min.
  • Severe valvular disease or likely to require surgery/TVAR within 3 years.
  • Life expectancy < 3 years due to non-cardiovascular comorbidity.
  • Enrolled in a competing clinical trial.
  • Prior intolerance to both an ACE-I and ARB.
  • If intolerant to a statin unless taking a PCSK9 as a statin replacement by their clinical provider.
  • Pregnancy (If they have not gone through menopause, had a hysterectomy, oophorectomy, or sterilization such as tubal ligation procedure, all pre-menopausal females must have negative urine pregnancy test if randomized to IMT before study drugs are prescribed).

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Amy Pollak, M.D.

Open for enrollment

Contact information:

Erika Douglass M.P.H.

(904) 953-6595

Douglass.Erika@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20502618

Mayo Clinic Footer