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| Name | Class |
|---|---|
| Tel Aviv Medical Center | OTHER |
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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 EndoPATâ„¢ 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
Study design and patient Selection One hundred and forty patients with the diagnosis of Non ST Elevation Myocardial Infarction (NSTEMI) 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 inform consent. Study will be published on NIH clinicaltrials.com database.
Inclusion and exclusion criteria are presented in Table 1 Table 1: Patient Selection Inclusion criteria
1. NSTEMI Diagnosis 2. Patients above the age of 18 3. Informed consent Exclusion criteria
Pre Study exam
After enrollment, patients will undergo the following baseline procedure:
Blood sampling An 18-gauge cannula will be placed in an antecubital vein for blood sampling. Blood sample analyses will be performed using reagents, calibrators and control materials from Bayer Diagnostics (Berkshire, England) on the ADVIA 1650. A 40 ml blood sample will be obtained as described below. Blood tests timing is detailed at the end in the flow chart.
Each Patient will provide 40ml of blood for the following blood tests
PAT score:
Peripheral arterial tonometry signals will be obtained using the EndoPAT 2000 device (Itamar Medical Inc., Caesarea, Israel), which has been validated and used previously to assess peripheral arterial tone in other populations. 14-17 Briefly, EndoPAT bio-sensors are placed on the index fingers of both arms. EndoPAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood flow causes an endothelium-dependent Flow Mediated Dilatation (FMD). The dilatation, manifested as reactive hyperemia, is captured by EndoPAT as an increase in the PAT Signal amplitude. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index. In addition, the EndoPAT system will measure heart rate variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | Colchicine 1mg per day for one month |
|
| Placebo | Placebo Comparator | Placebo 1mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | Colchicine 1mg per day for one month |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of RH-PAT at 1 month (a marker of endothelial function) | RH-PAT will be measured before the angiography and after one month. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in inflammatory biomarkers (before cardiac catheterization, after cardiac catheterization and at 1 month time follow-up) | biomarkers will be assessed before and after the angiography. Comparison of the biomarker levels will be assessed between the two treatment groups | 1 month |
| Improvement in endothelial function markers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaron Arbel, MD | Tel Aviv Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Medical Center | Tel Aviv | Israel | 64329 | Israel | ||
| Sourasky medical center (Ichilov) |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Drug |
Placebo |
|
|
serum ICAM VACAM and endothelin will be measured |
| 1 month |
| inflammatory biomarkers Improvement of heart rate variability (HRV) | 1 month |
| Changes in cholinergic status | serum ACHE will be measured at randomization and after one month | 1 month |
| Reduction of Acute Kidney Injury post PCI | AKI will be defined per AKIN as an increase of 0.3mg/dl. The two treatment groups will be compared | 1 month |
| Reduction in radial artery occlusion | acute |
| Reduction of peri-procedural myocardial infarction | 1 month |
| Major adverse clinical events (MACE) defined as a composite of all-cause mortality, myocardial infarction, repeat revascularization, and 30 day readmission rate | 1 month |
| quality of life under colchicine treatment | The investigators will assess this outcome using a standard quality of life questionnaire (EQ5). | 1 month |
| Safety | Safety will be assessed by comparing adverse events between the two groups | up to 1 year |
| Tel Aviv |
| Israel |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |