Post-MI PET Scan Imaging of Inflammation

NCT ID: NCT02281305

Last Updated: 2014-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Colchicine Active treatment group

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

Group Type EXPERIMENTAL

Colchicine

Intervention Type DRUG

Control group

Drug: Placebo

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Colchicine

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academy of Athens

OTHER

Sponsor Role collaborator

G.Gennimatas General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Spyridon Deftereos

Director, Cardiac Catheterization Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Constantinos Anagnostopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Foundation of Academy of Athens

Christos Angelidis, MD

Role: PRINCIPAL_INVESTIGATOR

Athens General Hospital "G. Gennimatas"

Locations

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Athens General Hospital "G. Gennimatas"

Athens, Attica, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Spyridon Deftereos, MD

Role: CONTACT

+302107768560

Georgios Giannopoulos, MD

Role: CONTACT

+302107768560

Facility Contacts

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spyridon Deftereos, MD

Role: primary

+302107768560

Other Identifiers

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22977 / 29-08-2014

Identifier Type: -

Identifier Source: org_study_id

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