Periprocedural Myocardial InfarctionNCT05745818
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
An observational study of Periprocedural Myocardial Infarction and Periprocedural Myocardial Injury, run by Sohag University.
Trial summary
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periprocedural Myocardial Infarction, Periprocedural Myocardial Injury
- What is being tested?
- Colchicine Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: IHD patients in IMD sohag university hospital prepared for elective PCI
Who may be able to join
- Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .
- PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).
- PPMI (rise in post-PCI troponin plus new evidence of ischemia).
Who cannot join
- Patients with active infections.
- Patients taking anti-inflammatory medications.
- Patients presented with ACS( still rising troponin).
- Severe renal impairment ( creatinine clearance < 45 ml/min ).
- Primary PCI, rescue PCI, pharmacoinvasive therapy.
- Connective tissue diseases.
About this study
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.
Read the detailed description
Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are:
- group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour. N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.)
- control group of patients. Number of patients according to sample size equation.
Sample size equation is used to calculate the minimum size of the required sample:
n = (z)2 p (1- p) / d2
- Number of patients according to sample size equation about 300 patients 150 patient in each group of study.
- Estimated study duration 2 years.
- N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on.
- Being tested
- Colchicine Pill
- Keywords
- Colchicine - PCI - PPMI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine PillDrug
oral pills
| Study group | Role | What they receive |
|---|---|---|
| colchicine group | Not described Receives: Drug: Colchicine Pill | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACEs
Major Adverse Cardiac Events
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periprocedural Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarik Mahmoud Abdellah, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745818
- Sponsor's protocol ID
- Colchicine study
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT05745818
- Acronym / sponsor ID
- Colchicine study
- Keywords
- Colchicine - PCI - PPMI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 27 Feb 2023 (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.
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.
Detailed description
Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are:
- group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour. N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.)
- control group of patients. Number of patients according to sample size equation.
Sample size equation is used to calculate the minimum size of the required sample:
n = (z)2 p (1- p) / d2
- Number of patients according to sample size equation about 300 patients 150 patient in each group of study.
- Estimated study duration 2 years.
- N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| colchicine group | – | Drug: Colchicine Pill |
| control group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- IHD patients in IMD sohag university hospital prepared for elective PCI
Key inclusion criteria (3 listed)
- Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .
- PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).
- PPMI (rise in post-PCI troponin plus new evidence of ischemia).
Key exclusion criteria (6 listed)
- Patients with active infections.
- Patients taking anti-inflammatory medications.
- Patients presented with ACS( still rising troponin).
- Severe renal impairment ( creatinine clearance < 45 ml/min ).
- Primary PCI, rescue PCI, pharmacoinvasive therapy.
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 Pilloral pills | Drug | colchicine group |
Primary outcome
MACEs
Time frame: one month
Major Adverse Cardiac Events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periprocedural Myocardial Infarction and Periprocedural Myocardial Injury, run by Sohag University.
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 3 inclusion and 6 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 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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?
MACEs (time frame: one month). 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 27 Feb 2023.