Acute Myocardial InfarctionPhase 4NCT02281305
Post-MI PET Scan Imaging of Inflammation
A Phase 4 study testing Colchicine in people with Acute Myocardial Infarction, run by G.Gennimatas General Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2014to Apr 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Athens General Hospital "G. Gennimatas"
Athens, Attica, 11527
spyridon Deftereos, MD, +302107768560, spdeftereos@gmail.com
About this study
Official title: Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine
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
- Being tested
- Colchicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
| Study group | Role | What they receive |
|---|---|---|
| Colchicine Active treatment group | Experimental | Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days Receives: Drug: Colchicine |
| Control group | Placebo comparator | Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of inflammation of the involved myocardium as assessed by the PET scan
Measured: 5 days post-MI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G.Gennimatas General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Athens
- Responsible party
- Principal investigator, Spyridon Deftereos, G.Gennimatas General Hospital
- Investigators
- Constantinos Anagnostopoulos, MD, Principal investigator, Biomedical Research Foundation of Academy of AthensChristos Angelidis, MD, Principal investigator, Athens General Hospital "G. Gennimatas"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281305
- Sponsor's protocol ID
- 22977 / 29-08-2014
- Status last verified
- Oct 2014
- First submitted
- 30 Oct 2014
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine
- ClinicalTrials.gov ID
- NCT02281305
- Acronym / sponsor ID
- 22977 / 29-08-2014
- Conditions
- Acute Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- G.Gennimatas General HospitalUniversity, hospital or other
- Collaborators
- Academy of Athens
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (estimated)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine Active treatment group | Experimental | Drug: ColchicineDrug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days |
| Control group | Placebo comparator | –Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- Excluded patients:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine | Drug | Colchicine Active treatment group |
Primary outcome
Degree of inflammation of the involved myocardium as assessed by the PET scan
Time frame: 5 days post-MI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constantinos Anagnostopoulos, MD principal investigator
Biomedical Research Foundation of Academy of Athens
Christos Angelidis, MD principal investigator
Athens General Hospital "G. Gennimatas"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colchicine in people with Acute Myocardial Infarction, run by G.Gennimatas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Spyridon Deftereos, MD (+302107768560, spdeftereos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of inflammation of the involved myocardium as assessed by the PET scan (time frame: 5 days post-MI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.