COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction (COLD-MI)

September 24, 2025 updated by: University Hospital, Montpellier
This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

COLD-MI study aims to explore colchicine's impact on myocardial denervation following reperfused acute myocardial infarction. Acute myocardial infarction is the leading cause of heart failure (HF). It induces myocardial denervation predisposing to ventricular rhythm disorders and death. This denervation linked to infarction's size occurs by direct ischaemic mechanisms during the initial coronary occlusion (initially non-vascularised zone) and secondarily by cardiac remodelling in the context of the heart failure (HF). In usual practice, cardiac denervation which intensity is correlated with rhythm and mortality risks, can be evaluated by scintigraphy. In a murine reperfusion model of ischemia, the direct anti-inflammatory effect of colchicine reduces the size of the necrosis and improves post-ischemic remodeling. This suggests that colchicine may reduce myocardial denervation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

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

  • France
      • Montpellier, France, 34090
        • UH Montpellier

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age from 18 to 80 year old
  • Hospitalization within 12 hours of onset of acute chest pain
  • Patient must have suffered a documented acute myocardial infarction
  • Coronary occlusion on initial angiography (culprit artery with aTIMI (Thrombolysis in Myocardial Infarction) flow 1 or 0)
  • Patient eligible for a revascularization procedure by PTCA (Percutaneous transluminal coronary angioplasty)

Exclusion Criteria:

  • Patients with a history of myocardial infarction prior to the current episode
  • Patient in cardiogenic shock or with hemodynamic instability
  • Patients with severe hepatic or renal dysfunction (GFR ≤30 mL/min)
  • Pregnant women or women of childbearing age without contraception
  • Treatment with a potent CYP3A4 inhibitor or a P-glycoprotein inhibitor in patients with renal or hepatic impairement
  • Association with macrolides (except spiramycin)
  • Association with pristinamycin

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Colchicine
colchicine and standard therapy
Drug: Colchicine
1 mg (or 0.5mg) tablet of colchicine taken once a day for 1 month
Other Names:
  • no other name
No Intervention: Comparator
standard therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of myocardial denervation
Time Frame: 6 month
assess by MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging
6 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in the heart-to-mediastinum ratio
Time Frame: 6 month
The heart-to-mediastinum (H/M) ratio, the heart count normalized for the mediastinum count, is used as a quantitative index in cardiac 123 I-MIBG imaging.
6 month
Left Ventricular Ejection Fraction in percent
Time Frame: 6 month
By transthoracic echocardiogram (TTE)
6 month
Left Ventricular Ejection Fraction in percent
Time Frame: 6 month
By MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging
6 month
Left Ventricular Ejection Fraction in percent
Time Frame: 1 month
By transthoracic echocardiogram (TTE)
1 month
Change in Sinus variability
Time Frame: 6 month
by 24 hours holter recording : SDNN (Standard Deviation of NN intervals) will be measured
6 month
Change in Sinus variability
Time Frame: 1 month
by 24 hours holter recording : SDNN (Standard Deviation of NN intervals) will be measured
1 month
Basic ECG parameters (QRS duration)
Time Frame: 6 month
6 month
Basic ECG parameters (QRS duration)
Time Frame: 1 month
1 month
Basic ECG parameters (corrected QT)
Time Frame: 1 month
1 month
Basic ECG parameters (corrected QT)
Time Frame: 6 month
6 month
Number of ventricular extrasystole (2 or 3 VES) per 24 hours on the Holter
Time Frame: 6 month
6 month
Number of bursts (2 or 3 VES) per 24 hours on the Holter
Time Frame: 1 month
1 month
Number of bursts (2 or 3 VES) per 24 hours on the Holter
Time Frame: 6 month
6 month
Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours
Time Frame: 1 month
1 month
Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours
Time Frame: 6 month
6 month
Time from randomization to death (total mortality)
Time Frame: 6 month
6 month
Time from randomization to heart failure hospitalization
Time Frame: 6 month
6 month
Time from randomization to all-cause hospitalization
Time Frame: 6 month
6 month
Variations in the levels of neurotrophic molecular markers
Time Frame: Between hospitalization and 1 month
Concentration of NGF ng/mL
Between hospitalization and 1 month
Variations in the levels of neurotrophic molecular markers
Time Frame: Between 1 month and 6 months
Concentration of NGF ng/mL
Between 1 month and 6 months
Variations in the levels of neurotrophic molecular markers
Time Frame: Between hospitalization and 1 month
Concentration of proNGF ng/mL
Between hospitalization and 1 month
Variations in the levels of neurotrophic molecular markers
Time Frame: Between 1 month and 6 months
Concentration of proNGF ng/mL
Between 1 month and 6 months
Variations in the levels of neurotrophic molecular markers
Time Frame: Between hospitalization and 1 month
Concentration of BDNF ng/mL
Between hospitalization and 1 month
Variations in the levels of neurotrophic molecular markers
Time Frame: Between 1 month and 6 months
Concentration of BDNF ng/mL
Between 1 month and 6 months
Biological evaluation of infarction size Creatine PhosphoKinase (CPK)
Time Frame: During hospitalization (Day 1 to Day 5)
Area Under Curve (AUC) of CPK
During hospitalization (Day 1 to Day 5)
Biological evaluation of infarction size (troponin)
Time Frame: During hospitalization (Day 1 to Day 5)
Area Under Curve (AUC) of Troponin
During hospitalization (Day 1 to Day 5)
Post infarction systemic inflammation evaluation
Time Frame: Between hospitalization and 1 month
Concentration of biomarkers from blood : CRP (mg/L)
Between hospitalization and 1 month
Post infarction systemic inflammation evaluation
Time Frame: Between 1 month and 6 months
Concentration of biomarkers from blood : CRP (mg/L)
Between 1 month and 6 months
Post infarction systemic inflammation evaluation
Time Frame: Between hospitalization and 1 month
Concentration of biomarkers from blood : sST2 (ng/mL)
Between hospitalization and 1 month
Post infarction systemic inflammation evaluation
Time Frame: Between 1 month and 6 months
Concentration of biomarkers from blood : sST2 (ng/mL)
Between 1 month and 6 months
Infarct size in percentage of left ventricular
Time Frame: 6 month
6 month
Number of Adverse event
Time Frame: from randomization to 6 months
Comparison of adverse events between 2 arms
from randomization to 6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL18_0459
  • 2020-000098-25 (Registry Identifier: EudraCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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