CIGB-500 in acute myocardial infarction (AMIGOS study)

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

AMIGOS study

Scientific title:

Administration CIGB-500 in patients with acute myocardial infarction treated with primary coronary angioplasty.

Secondary indentifying numbers:

IG/CIGB-500I/IM/1301

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB) Ministry of Public Health, CUBA

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

05-008-13-BA (Procedure code), September 24, 2013. (In process)

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Juan

Last name:

Valiente Mustelier

Medical Specialty :

2nd Degree Specialist in Cardiology

Affiliation:

Institute of Cardiology and Cardiovascular Surgery

Postal address:

Calle 17 y Paseo, Vedado, Plaza de la Revolución.

City:

Havana

Country:

Cuba

Zip Code:

12100

Telephone:

+53-78386021

Email address:

jvaliente@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Villa Clara, "Ernesto Guevara" Cardiocenter, Alberto Morales Salinas, 2nd Degree Specialist in Cardiology and Intensive Care.

Research ethics committees:

Institute of Cardiology and Cardiovascular Surgery, May 29, 2013.

"Ernesto Guevara" Cardiocenter, May 21, 2013.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

05/09/2014

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Acute myocardial infarction

Intervention(s):

Group I: Peptide CIGB-500 (50 µg/kg) applied in IV bolus, slowly, for 3 minutes. Each patient will receive 14 administrations: a 1st dose after Percutaneous Transluminal Coronary Angioplasty (PTCA) and then every 12 hours for 7 days. Group II: Peptide CIGB-500 (100 µg/kg) applied in IV bolus, slowly, for 3 minutes. Each patient will receive 14 administrations: a 1st dose after Percutaneous Transluminal Coronary Angioplasty (PTCA) and then every 12 hours for 7 days.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Clinical adverse event (AE). Measuring time: daily in the 1st week , 1st month weekly (weeks 2, 3 and 4) and monthly until 6 months . EA - Occurrence (Yes, No) - EA Description (name of event) EA - intensity (mild, moderate , severe). Vital signs (temperature, blood pressure, heart rate and respiratory rate). Measuring time: 30 minutes after initiation of treatment, every hour (the first 8 hours) , then every 2 hours (for up to 24 hours) , followed every 4 hours while the patient remains hospitalized. At discharge, each query evaluation. Electrocardiogram (ST-segment abnormalities and the relation of the QT/QTc interval). Measuring time: daily during hospitalization and at each outpatient evaluation. Laboratory (numerical values of hematological, biochemical tests and biomarkers). Measuring time: 72 hours at hospital discharge and at months 1, 3 and 6.

Key secondary outcomes:

Echocardiographic evidence (study of ventricular function: ejection fraction of the left ventricle, diastolic and systolic left ventricular volume, wall motion score index). Measuring time: 24 hours after primary PTCA, at 72 hours, at 2 and 6 months. Extension of the infarct (by two-dimensional echocardiography and scintigraphy). Measuring time: at baseline and at 4-6 weeks post-inclusion. Pro-inflammatory markers (IL-1β, IL-6, CRP, TNF alpha). Measuring time: at 12, 24 and 72 hours, the 5th day and at hospital discharge. Markers REDOX system (MDA, H2O2, peroxidation potential serum SOD, CAT, GSH, NO FLAP FRAP, ferric reducing ability of iron, PAOP). Measuring time: 72 hours and at hospital discharge.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

30 years

Maximum age:

65 years

Inclusion criteria:

1) Compliance with the diagnostic criteria. 2) Patient presenting their first acute myocardial infarction (AMI). 3) Voluntary patient by providing their informed consent (oral).

Exclusion criteria:

1) Cardiogenic shock as a presentation. 2) significant coronary multivessel disease. 3) Patients previously revascularized. 4) diabetics or with a history of pituitary adenoma patients. 5) Patients with a diagnosis of malignancy. 6) Pregnancy or lactation at the time of inclusion in the study (reported by the patient). 7) Mental incapacity apparent consent to issue and act accordingly to the study.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Dose comparison

Study design:

Parallel

Phase:

1-2

Target sample size:

20

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Francisco

Last Name:

Hernandez Bernal

Specialty:

2nd Degree Specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

hernandez.bernal@cigb.edu.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Francisco

Last Name:

Hernandez Bernal

Specialty:

2nd Degree Specialist in Hygiene and Epidemiology

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

(53-7)-2085887, 2087465

Email :

hernandez.bernal@cigb.edu.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000177

Date of Registration in Primary Registry:

23/04/2014

Record Verification Date:

2014/04/16

Next update date:

2015/04/16

Link to the spanish version:

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CIGB-500 in acute myocardial infarction (AMIGOS study)

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