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
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