Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking

August 19, 2022 updated by: Mohamed Radwan, Ain Shams University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

▪︎Anterior S-T segment elevation myocardial infarction with time of presentation less than 12 hours.

Exclusion Criteria:

  • Severe renal impairment.
  • Cardiac arrest.
  • Cardiogenic shock.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colchicine 0.5 mg oral tablet
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
Drug: Colchicine 0.5 mg Oral Tablet
Colchicine loading dose 1 mg and maintenance dose 0.5 mg for 6 months in addition to standard anti ischemic treatment.
Other Names:
  • Standard anti ischemic treatment
No Intervention: Standard anti ischemic treatment
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of mortality during study
Time Frame: 6 months
Death from any cause
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Mohamed Radwan, Master, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

December 20, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

August 23, 2022

Last Update Submitted That Met QC Criteria

August 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASUMD88/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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