Overview

COlchicine Improve EnDothElial Function in Non ST Elevation Myocardial Infarction Patients

Status:
Withdrawn
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
Colchicine has antiinflammatory properties. It has been shown to be effective in improving outcome in stable coronary disease. The exact mechanism is unclear. Study objective: to assess the effect of colchicine on endothelial function using the EndoPAT™ in NSTEMI Patients. Study Hypothesis: There will be a significant difference on the RH-PAT levels of the patients who were in treated with colchicine versus the placebo group Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction will be enrolled to a prospective randomized double-blind placebo controlled study in Tel Aviv Medical Center, Tel Aviv, Israel. Patients will be recruited during their hospitalization before cardiac catheterization. All patients will sign an informed consent. Primary outcome will be the improvement in endothelial function between baseline and after 1 month in both groups
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborator:
Tel Aviv Medical Center
Treatments:
Colchicine
Criteria
Inclusion Criteria:

1. NSTEMI Diagnosis

2. Patients above the age of 18

3. Informed consent

Exclusion Criteria:

1. Hemodynamic instability

2. Pregnant women

3. Peripheral vascular disease with feeble or absent peripheral pulses

4. Restlessness and/or chaotic breathing

5. Renal dialysis

6. Severe aortic valve insufficiency/Stenosis

7. Severe mitral valve insufficiency

8. Congenital cardiac malformations (structural heart diseases)

9. Known extra-cardiac shunts

10. Major surgery within 30 days

11. Any medical condition that would impair participation (e.g. progressive neurological
disorders, mental illness)

12. Known intolerance to colchicine

13. Ejection fraction less than 35% or past admission for CHF exacerbation in the last 30
days.

14. Inflammatory diseases

15. Current treatment with steroids, NSAID, chemotherapy or biologic medications