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Post-MI PET Scan Imaging of Inflammation

Primary Purpose

Acute Myocardial Infarction

Status

Unknown status

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

Colchicine

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Athens General Hospital "G. Gennimatas"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine Active treatment group

Control group

Arm Description

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

Drug: Placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02281305

First Posted

October 30, 2014

Last Updated

October 31, 2014

Sponsor

G.Gennimatas General Hospital

Collaborators

Academy of Athens

1. Study Identification

Unique Protocol Identification Number

NCT02281305

Brief Title

Post-MI PET Scan Imaging of Inflammation

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

G.Gennimatas General Hospital

Collaborators

Academy of Athens

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myocardial Infarction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colchicine Active treatment group

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Drug: Placebo

Intervention Type

Drug

Intervention Name(s)

Colchicine

Primary Outcome Measure Information:

Title

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

Time Frame

5 days post-MI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Spyridon Deftereos, MD

Phone

+302107768560

spdeftereos@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Georgios Giannopoulos, MD

Phone

+302107768560

ggiann@med.uoa.gr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Constantinos Anagnostopoulos, MD

Organizational Affiliation

Biomedical Research Foundation of Academy of Athens

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Christos Angelidis, MD

Organizational Affiliation

Athens General Hospital "G. Gennimatas"

Official's Role

Principal Investigator

Facility Information:

Facility Name

Athens General Hospital "G. Gennimatas"

City

Athens

State/Province

Attika

ZIP/Postal Code

11527

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

spyridon Deftereos, MD

Phone

+302107768560

spdeftereos@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Post-MI PET Scan Imaging of Inflammation

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