NCT05200052

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

December 20, 2021

Last Update Submit

August 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Average of global longitudinal strain pattern

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

    6 months

Secondary Outcomes (1)

  • Number of mortality during study

    6 months

Study Arms (2)

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

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

Interventions

Colchicine loading dose 1 mg and maintenance dose 0.5 mg for 6 months in addition to standard anti ischemic treatment.

Also known as: Standard anti ischemic treatment
Colchicine 0.5 mg oral tablet

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Anterior Wall Myocardial Infarction

Interventions

ColchicineTablets

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Officials

  • Mohamed Radwan, Master

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 20, 2021

First Posted

January 20, 2022

Study Start

February 1, 2022

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

August 23, 2022

Record last verified: 2022-08

Locations