Post-MI PET Scan Imaging of Inflammation

NCT02281305 | Unknown Phase 4 DMC

• 1 other identifier: 22977 / 29-08-2014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Degree of inflammation of the involved myocardium as assessed by the PET scan

  5 days post-MI

Study Arms (2)

Colchicine Active treatment group

EXPERIMENTAL

Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days

Drug: Colchicine

Control group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Colchicine DRUG

Colchicine Active treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• G.Gennimatas General Hospital: lead
• Academy of Athens: collaborator

Study Sites (1)

Athens General Hospital "G. Gennimatas"

Athens, Attica, 11527, Greece

RECRUITING

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Constantinos Anagnostopoulos, MD

  Biomedical Research Foundation of Academy of Athens

  PRINCIPAL INVESTIGATOR

• Christos Angelidis, MD

  Athens General Hospital "G. Gennimatas"

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Spyridon Deftereos, MD

CONTACT

+302107768560; spdeftereos@gmail.com

Georgios Giannopoulos, MD

CONTACT

+302107768560; ggiann@med.uoa.gr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Catheterization Department

Study Record Dates

• First Submitted: October 30, 2014
• First Posted: November 3, 2014
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Last Updated: November 3, 2014

Record last verified: 2014-10

Locations

GR (1)