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

Primary Purpose

Anterior MI, Colchicine

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Colchicine 0.5 mg Oral Tablet
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior MI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Colchicine 0.5 mg oral tablet

Standard anti ischemic treatment

Arm Description

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

100 patients presented with anterior myocardial infarction undergoing primary percutaneous coronary intervention will do longitudinal strain pattern echocardiography to asses left ventricles systolic function

Outcomes

Primary Outcome Measures

Average of global longitudinal strain pattern
Assessment of left ventricular longitudinal strain by speckle tracking echocardiography after beforr and after colchicine

Secondary Outcome Measures

Number of mortality during study
Death from any cause

Full Information

First Posted
December 20, 2021
Last Updated
August 19, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05200052
Brief Title
Effect of Colchicine On Left Ventricle Function After Anterior Myocardial Infarction Assessed By Speckle Tracking
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior MI, Colchicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Colchicine 0.5 mg oral tablet
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard anti ischemic treatment
Arm Type
No Intervention
Arm Description
100 patients presented with anterior myocardial infarction undergoing primary percutaneous coronary intervention will do longitudinal strain pattern echocardiography to asses left ventricles systolic function
Intervention Type
Drug
Intervention Name(s)
Colchicine 0.5 mg Oral Tablet
Other Intervention Name(s)
Standard anti ischemic treatment
Intervention Description
Colchicine loading dose 1 mg and maintenance dose 0.5 mg for 6 months in addition to standard anti ischemic treatment.
Primary Outcome Measure Information:
Title
Average of global longitudinal strain pattern
Description
Assessment of left ventricular longitudinal strain by speckle tracking echocardiography after beforr and after colchicine
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of mortality during study
Description
Death from any cause
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed Radwan, Master
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University hospitals
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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