Cardiogenic ShockLATIN-SHOCKNCT05246683
LATIN SHOCK: Latin American Registry of Cardiogenic Shock in the Context of Acute Coronary Syndrome
An observational study of Cardiogenic Shock and Acute Coronary Syndrome, run by Sociedad Argentina de Cardiología at 1 site in Argentina.
Trial summary
This is a Registry of the characteristics and clinical evolution of patients admitted for acute coronary syndromes (with or without st segment elevation) who present with cardiogenic shock or develop it during the hospitalization period. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cardiogenic Shock, Acute Coronary Syndrome
- What is being tested?
- observational
- How many people
- 700 participants
- Where
- 1 siteArgentina
- Study dates
- 15 Feb 2022to 18 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute cardiac syndrome with or without st elevation and cardiogenic shock as a complication. Includes cardiogenic shock at presentation or during hospitalario period
Inclusion Criteria:Patients of both sexes and older than 18 years, admitted to the unit coronary or polyvalent critical care, for an acute coronary syndrome with or without ST-segment elevation presenting cardiogenic shock from the admission or develop it during the hospitalization and that can be followed in its evolution until hospital discharge. -
Exclusion Criteria:Non-ischemic cardiogenic shock (chronic heart failure, myocarditis, sepsis, tachycardiomyopathies, Takotsubo, etc.). Cardiogenic shock A and B of the new SCAI classification
-
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Sociedad Argentina de Cardiologia
Buenos Aires, Buenos Aires F.D., C1115
Yanina B Castillo Costa, md, 0054 11 14975459, yanu_c@hotmail.com
Victor M Mauro, md, 00541144016567, victormauro@uolsinectis.com.ar
About this study
Official title: LATIN SHOCK: Registro Latinoamericano de Shock Cardiogénico en el Contexto de Los Sindromes Coronarios Agudos
This is a Registry of the characteristics and clinical evolution of patients admitted for acute coronary syndromes (with or without st segment elevation) who present with cardiogenic shock or develop it during the hospitalization period.
Cardiogenic shock is a rare pathology, but it constitutes the leading cause of mortality in patients hospitalized for acute infarction myocardium. Its incidence ranges between 7 and 10% of the cases of infarction1 and is associated with a mortality of 40-50% despite revascularization and the use of Intra-Aortic Counterpulsation Balloon. Most of the bibliography on this subject is North American and has a lot of years and the one currently published shows mostly the results of different ventricular supports that are not used routinely in our countries. So far there is no record that reports the reality of Latin America. Only in Argentina, a registry has been carried out (Re Na Shock) but more than 5 years have passed since its publication. In the last years have even changed the management guidelines for this pathology and have been published works that could have changed previous behaviors
. This is a project of the Argentine Society of Cardiology to collect data epidemiological and current management of cardiogenic shock in Latin America.
Read the detailed description
It is an international, multicenter, observational registry of prospective and consecutive patients with cardiogenic shock in the context of acute coronary syndromes, which will last 12 months from its start on December 4, 2021. Coronary Units will be invited to participate from different Latin American countries through the different cardiology societies. It will be assigned to each country and each participant center a number and patients will be entered into the registry in correlative order by center (1-2-3-etc) to maintain the confidentiality of the patients data. Since the patient data will be extracted from the medical records, the records will be anonymous and there will be no follow-up, no informed consent is required. The names of the participating centers of the different countries will appear in a list at the end of the publications, under the collective name of "LATIN Shock group".
Definition of cardiogenic shock (classic): presence of systolic blood pressure
≤ 90 mm Hg for 30 minutes or requirement of vasopressors, inotropics and / or ventricular supports to maintain a blood pressure ≥ 90 mm Hg, associated with signs of hypoperfusion and pulmonary congestion, in the absence of hypovolemia or arrhythmias that justify the clinical picture. A new definition of cardiogenic shock has recently been proposed (SCAI), which includes 5 categories. In this work, patients with cardiogenic shock only those with C, D and E letter will be included.
- Conditions
- Cardiogenic Shock, Acute Coronary Syndrome
- Being tested
- observational
- Medical subject headings
- Shock, Cardiogenic, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
registry
| Study group | Role | What they receive |
|---|---|---|
| cohort | Observational evaluation during the hospital stage on diagnosis, treatment and evolution of patients with cardiogenic shock. Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Register through the survey modality the incidence of the clinical characteristics of the patients admitted to the coronary unit with acute coronary syndromes and cardiogenic shock, either from admission or during its in-hospital evolution.
characteristics
Measured: 1 year
To analyze the treatment and diagnostics methods of patients with cardiogenic shock during hospital stay.
treatment
Measured: 1 year
Observe in-hospital clinical evolution and incidence of complications of patients with cardiogenic shock.
evolution
Measured: 1 year
Secondary outcomes (2)
Find predictors of in-hospital mortality.
predictors
Measured: 1 year
To compare the clinical, management and evolution characteristics in the different participating Latin American countries.
compare
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start15 Feb 2022
- Primary completion18 Dec 2022 (estimated)
- Study completion18 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sociedad Argentina de Cardiología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victor M Mauro, md, Study director, Sociedad Argentina de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246683
- Sponsor's protocol ID
- LATIN SHOCK
- Acronym
- LATIN-SHOCK
- Status last verified
- Feb 2022
- First submitted
- 26 Dec 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LATIN SHOCK: Registro Latinoamericano de Shock Cardiogénico en el Contexto de Los Sindromes Coronarios Agudos
- ClinicalTrials.gov ID
- NCT05246683
- Acronym / sponsor ID
- LATIN-SHOCK / LATIN SHOCK
- Conditions
- Cardiogenic Shock, Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Sociedad Argentina de CardiologíaUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 18 Dec 2022 (estimated)
- Study completion
- 18 Dec 2022 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Registry of the characteristics and clinical evolution of patients admitted for acute coronary syndromes (with or without st segment elevation) who present with cardiogenic shock or develop it during the hospitalization period.
Cardiogenic shock is a rare pathology, but it constitutes the leading cause of mortality in patients hospitalized for acute infarction myocardium. Its incidence ranges between 7 and 10% of the cases of infarction1 and is associated with a mortality of 40-50% despite revascularization and the use of Intra-Aortic Counterpulsation Balloon. Most of the bibliography on this subject is North American and has a lot of years and the one currently published shows mostly the results of different ventricular supports that are not used routinely in our countries. So far there is no record that reports the reality of Latin America. Only in Argentina, a registry has been carried out (Re Na Shock) but more than 5 years have passed since its publication. In the last years have even changed the management guidelines for this pathology and have been published works that could have changed previous behaviors
. This is a project of the Argentine Society of Cardiology to collect data epidemiological and current management of cardiogenic shock in Latin America.
Detailed description
It is an international, multicenter, observational registry of prospective and consecutive patients with cardiogenic shock in the context of acute coronary syndromes, which will last 12 months from its start on December 4, 2021. Coronary Units will be invited to participate from different Latin American countries through the different cardiology societies. It will be assigned to each country and each participant center a number and patients will be entered into the registry in correlative order by center (1-2-3-etc) to maintain the confidentiality of the patients data. Since the patient data will be extracted from the medical records, the records will be anonymous and there will be no follow-up, no informed consent is required. The names of the participating centers of the different countries will appear in a list at the end of the publications, under the collective name of "LATIN Shock group".
Definition of cardiogenic shock (classic): presence of systolic blood pressure
≤ 90 mm Hg for 30 minutes or requirement of vasopressors, inotropics and / or ventricular supports to maintain a blood pressure ≥ 90 mm Hg, associated with signs of hypoperfusion and pulmonary congestion, in the absence of hypovolemia or arrhythmias that justify the clinical picture. A new definition of cardiogenic shock has recently been proposed (SCAI), which includes 5 categories. In this work, patients with cardiogenic shock only those with C, D and E letter will be included.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort | – | Other: observationalObservational evaluation during the hospital stage on diagnosis, treatment and evolution of patients with cardiogenic shock. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute cardiac syndrome with or without st elevation and cardiogenic shock as a complication. Includes cardiogenic shock at presentation or during hospitalario period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationalregistry | Other | cohort |
Primary outcome
Register through the survey modality the incidence of the clinical characteristics of the patients admitted to the coronary unit with acute coronary syndromes and cardiogenic shock, either from admission or during its in-hospital evolution.
Time frame: 1 year
characteristics
To analyze the treatment and diagnostics methods of patients with cardiogenic shock during hospital stay.
Time frame: 1 year
treatment
Observe in-hospital clinical evolution and incidence of complications of patients with cardiogenic shock.
Time frame: 1 year
evolution
2 secondary outcomes
Find predictors of in-hospital mortality.
Time frame: 1 year
To compare the clinical, management and evolution characteristics in the different participating Latin American countries.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Individual participant dataSharing planned: Undecided
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Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
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Capital Offload-Shock
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victor M Mauro, md study director
Sociedad Argentina de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Acute Coronary Syndrome, run by Sociedad Argentina de Cardiología at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanina B Castillo Costa, md (00541141975459, yanu_c@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Register through the survey modality the incidence of the clinical characteristics of the patients admitted to the coronary unit with acute coronary syndromes and cardiogenic shock, either from admission or during its in-hospital evolution. (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.