Phase 4 Heart Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 years or older.
• People who have coronary artery disease (narrowing or blockage of the heart's arteries) and are having a procedure to open a blocked artery, where a special imaging device is used inside the artery during the procedure.
• People who have at least one major heart artery (not previously treated or bypassed) that meets all of the following:
  • The artery shows at least 30% narrowing as seen on an X-ray imaging test of the heart arteries.
  • The artery can be reached by the imaging device, specifically within the first 50mm of the artery.
  • The artery is not an artificial bypass graft or a vessel that has already been bypassed.
  • The section of the artery being looked at has not previously had an artery-opening procedure done on it.
  • The artery is not planned to have an artery-opening procedure done at the time of the study, or within 6 months after (as decided by the treating doctor).
• People who have given written consent to take part in the study.

Who may not be able to join:

• People who have a significant narrowing (50% or more) in the left main coronary artery (a major artery that supplies the heart).
• People who have previously had heart bypass surgery.
• People who are in an unstable medical condition, such as having an unstable heart rhythm or unstable blood pressure at the time of the procedure.
• People whose heart arteries have severe calcium build-up or unusual twisting that would interfere with the imaging devices used in the study.
• People who have had an uncontrolled or recurring heart rhythm problem — such as a fast or irregular heartbeat — that was not managed with medication in the 3 months before entering the study.
• People with active liver disease or poor liver function.
• People with severely reduced kidney function (confirm with trial site for specific test values).
• People with a known allergy to contrast dye (used in X-ray imaging), heparin, aspirin, ticagrelor, or prasugrel (these are blood-thinning or antiplatelet medications).
• People with an active infection or significant problems with blood, metabolism, or hormone function, as determined by the study doctor.
• People who have surgery planned within 12 months.
• People who are currently taking part in another clinical trial involving an investigational drug or device.
• People whose life expectancy is less than 2 years.
• Women under the age of 50 who have had a menstrual period within the last 12 months and have not had a tubal ligation, removal of the ovaries, or removal of the uterus.

Important: Always verify eligibility with the trial site directly before applying.