Anterior MIPhase 4NCT05200052
Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking
A Phase 4 study testing Colchicine 0.5 mg Oral Tablet in people with Anterior MI and Colchicine, run by Ain Shams University at 1 site in Egypt.
Trial summary
Effect of colchicine use on Left ventricles systolic function in patients with anterior S-T elevation myocardial infarction undergoing primary Percutaneous coronary intervention by using speckle tracking Echocardiography longitudinal strain pattern Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anterior MI, Colchicine
- What is being tested?
- Colchicine 0.5 mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2022to 1 Aug 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ▪︎Anterior S-T segment elevation myocardial infarction with time of presentation less than 12 hours.
Who cannot join
- Severe renal impairment.
- Cardiac arrest.
- Cardiogenic shock.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Colchicine Use On Left Ventricle Systolic Function Using Speckle Tracking Echocardiography in Patients With Anterior S-T Segment Elevation Myocardial Infarction
Effect of colchicine use on Left ventricles systolic function in patients with anterior S-T elevation myocardial infarction undergoing primary Percutaneous coronary intervention by using speckle tracking Echocardiography longitudinal strain pattern
Read the detailed description
The study participants are patients presented with anterior myocardial infarction.
They will be divided into 2 groups. The first group will receive colchicine loading dose of 1mg then 0.5 mg maintenance dose in addition to the standard anti ischemic treatment for 6 months.
The other group will only receive the standard anti ischmic treatment. Speckle tracking echocardiography will be done to all patients to assess left ventricular longitudinal strain pattern.
- Conditions
- Anterior MI, Colchicine
- Being tested
- Colchicine 0.5 mg Oral Tablet
- Medical subject headings
- Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 mg Oral TabletDrug
Also called Standard anti ischemic treatment
Colchicine loading dose 1 mg and maintenance dose 0.5 mg for 6 months in addition to standard anti ischemic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine 0.5 mg oral tablet | Active comparator | 100 patients presented with anterior Myocardial infarction undergoing primary Percutaneous coronary intervention will receive colchicine tablet 1mg loading dose and colchicine 0.5 mg maintance dose for 6 months and will do longitudinal strain pattern echocardiography to asses left ventricles systolic function Receives: Drug: Colchicine 0.5 mg Oral Tablet |
| Standard anti ischemic treatment | No intervention | 100 patients presented with anterior myocardial infarction undergoing primary percutaneous coronary intervention will do longitudinal strain pattern echocardiography to asses left ventricles systolic function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of global longitudinal strain pattern
Assessment of left ventricular longitudinal strain by speckle tracking echocardiography after beforr and after colchicine
Measured: 6 months
Secondary outcomes (1)
Number of mortality during study
Death from any cause
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior MIStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Radwan, Ain Shams University
- Investigators
- Mohamed Radwan, Master, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200052
- Sponsor's protocol ID
- FMASUMD88/2020
- Status last verified
- Aug 2022
- First submitted
- 20 Dec 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Colchicine Use On Left Ventricle Systolic Function Using Speckle Tracking Echocardiography in Patients With Anterior S-T Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05200052
- Acronym / sponsor ID
- FMASUMD88/2020
- Conditions
- Anterior MI, Colchicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 20 Jan 2022 (actual)
- 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.
Effect of colchicine use on Left ventricles systolic function in patients with anterior S-T elevation myocardial infarction undergoing primary Percutaneous coronary intervention by using speckle tracking Echocardiography longitudinal strain pattern
Detailed description
The study participants are patients presented with anterior myocardial infarction.
They will be divided into 2 groups. The first group will receive colchicine loading dose of 1mg then 0.5 mg maintenance dose in addition to the standard anti ischemic treatment for 6 months.
The other group will only receive the standard anti ischmic treatment. Speckle tracking echocardiography will be done to all patients to assess left ventricular longitudinal strain pattern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine 0.5 mg oral tablet | Active comparator | Drug: Colchicine 0.5 mg Oral Tablet100 patients presented with anterior Myocardial infarction undergoing primary Percutaneous coronary intervention will receive colchicine tablet 1mg loading dose and colchicine 0.5 mg maintance dose for 6 months and will do longitudinal strain pattern echocardiography to asses left ventricles systolic function |
| Standard anti ischemic treatment | No intervention | –100 patients presented with anterior myocardial infarction undergoing primary percutaneous coronary intervention will do longitudinal strain pattern echocardiography to asses left ventricles systolic function |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ▪︎Anterior S-T segment elevation myocardial infarction with time of presentation less than 12 hours.
Key exclusion criteria (3 listed)
- Severe renal impairment.
- Cardiac arrest.
- Cardiogenic shock.
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 0.5 mg Oral TabletAlso: Standard anti ischemic treatmentColchicine loading dose 1 mg and maintenance dose 0.5 mg for 6 months in addition to standard anti ischemic treatment. | Drug | Colchicine 0.5 mg oral tablet |
Primary outcome
Average of global longitudinal strain pattern
Time frame: 6 months
Assessment of left ventricular longitudinal strain by speckle tracking echocardiography after beforr and after colchicine
1 secondary outcome
Number of mortality during study
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
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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.
Mohamed Radwan, Master principal investigator
Ain Shams University
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 0.5 mg Oral Tablet in people with Anterior MI and Colchicine, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Aug 2022. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average of global longitudinal strain pattern (time frame: 6 months). 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 23 Aug 2022.