Post-MI PET Scan Imaging of Inflammation

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02281305
• Other study ID #: 22977 / 29-08-2014
• Status: Recruiting
• Phase: Phase 4
• First received: October 30, 2014
• Last updated: October 31, 2014
• Start date: October 2014

Study information

• Verified date: October 2014
• Source: G.Gennimatas General Hospital
• Contact: Spyridon Deftereos, MD
• Phone: +302107768560
• Email: spdeftereos[@]gmail.com
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Myocardial Infarction

Intervention

Drug:
• Colchicine

Locations

Country	Name	City	State
Greece	Athens General Hospital "G. Gennimatas"	Athens	Attika

Sponsors (2)

Lead Sponsor	Collaborator
G.Gennimatas General Hospital	Academy of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of inflammation of the involved myocardium as assessed by the PET scan		5 days post-MI	No