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Post-MI PET Scan Imaging of Inflammation

Information source: G.Gennimatas General Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myocardial Infarction

Intervention: Colchicine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: G.Gennimatas General Hospital

Official(s) and/or principal investigator(s):
Constantinos Anagnostopoulos, MD, Principal Investigator, Affiliation: Biomedical Research Foundation of Academy of Athens
Christos Angelidis, MD, Principal Investigator, Affiliation: Athens General Hospital "G. Gennimatas"

Overall contact:
Spyridon Deftereos, MD, Phone: +302107768560, Email: spdeftereos@gmail.com

Summary

Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.

Clinical Details

Official title: Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Degree of inflammation of the involved myocardium as assessed by the PET scan

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The study will enroll patients 18 years old or older

- Who presented to the hospital within twelve (12) hours of the onset of chest pain

- Who had ST segment elevation > 1 mm in two contiguous limb leads or ST segment

elevation > 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels. Exclusion Criteria:

- Excluded patients:

- with age > 80 years old

- with active inflammatory diseases, infectious diseases or known malignancy

- under treatment with corticosteroids, anti-inflammatory agents or disease

modifying agents

- with known hypersensitivity-allergy to colchicine

- under chronic treatment with colchicine

- with severe renal failure (eGFR < 30 ml/min/1. 73 m2)

- with hepatic failure (Child - Pugh class B or C)

- presented with cardiac arrest

- presented with ventricular fibrillation

- presented with cardiogenic shock

- with stent thrombosis

- with angina within 48 hours before infarction

- with previous myocardial infarction in the affected territory

- with occlusion of the left main or left circumflex coronary or the right

coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)

Locations and Contacts

Spyridon Deftereos, MD, Phone: +302107768560, Email: spdeftereos@gmail.com

Athens General Hospital "G. Gennimatas", Athens, Attika 11527, Greece; Recruiting
spyridon Deftereos, MD, Phone: +302107768560, Email: spdeftereos@gmail.com
Additional Information

Starting date: October 2014
Last updated: October 31, 2014

Page last updated: August 20, 2015

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