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Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area (PHASE-MX)

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ClinicalTrials.gov Identifier: NCT03974581
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Diego Araiza-Garaygordobil, Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary:

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking, especially in developing countries.

The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.


Condition or disease Intervention/treatment
Myocardial Infarction, Acute Other: Primary percutaneous coronary intervention Other: Pharmacoinvasive strategy

Detailed Description:

For patients presenting with ST-elevation myocardial infarction (STEMI), immediate and timely reperfusion treatment is essential. The optimal choice between primary percutaneous coronary intervention (PPCI) and intravenous thrombolytic agents depends upon the timeliness of effective delivery, as well as the total ischemic time. While PPCI is widespread available in the USA and Europe, limited resources and lack of infrastructure means that patients with STEMI in low- and middle-income countries (LMICs) receive significantly less reperfusion therapy, and when they do, they are more prone to receive thrombolytic agents.

Pharmacoinvasive strategy (PIs) exploits the widespread availability of fibrinolysis and its early administration to restore some degree of myocardial blood flow, coupled with the complete restoration of the culprit coronary artery patency that can be obtained with subsequent angioplasty. Several trials have demonstrated the efficacy and safety of PIs when compared with PPCI; however, real-world data is lacking. The aim of this study was to compare safety and efficacy of PIs with PPCI in real-world patients with STEMI presenting to large geographical area.

PHASE-Mx study is a prospective, real-world registry including patients with STEMI finally treated at a large cardiovascular center. In brief, patients aged 18-99 years old with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset were included. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network. Patients with a discharge diagnosis other than STEMI were excluded. Four of the investigators recorded the study data at admission and during hospital stay. Main efficacy outcome will be the composite of cardiovascular death, cardiogenic shock, reinfarction or stroke. Main safety outcome will include rates of major bleeding.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 326 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Pharmacoinvasive Strategy vs. Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction: A Prospective, Real-World Registry in a Large Geographical Area
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort Intervention/treatment
Pharmacoinvasive strategy
Patients whom received pharmacoinvasive strategy (fibrinolysis and subsequently PCI) as reperfusion treatment.
Other: Primary percutaneous coronary intervention
Patient receives primary percutaneous coronary intervention as part of his treatment; decision to allocate by treating physician.
Other Name: Primary PCI

Primary PCI
Patients whom primary PCI as reperfusion treatment.
Other: Pharmacoinvasive strategy
Patient receives primary fibrinolysis and subsequent coronary angiography (pharmacoinvasive strategy) as part of his treatment; cases with failed fibrinolysis are scheduled for immediate rescue PCI. Decision to allocate by treating physician.




Primary Outcome Measures :
  1. Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke. [ Time Frame: 30-days follow-up. ]
    Main efficacy combined outcome including cardiovascular mortality, cardiogenic shock, reinfarction and stroke.


Secondary Outcome Measures :
  1. Major bleeding [ Time Frame: Major bleeding during a 30-days follow-up. ]
    Major bleeding during a 30-days follow-up.

  2. All-cause mortality [ Time Frame: 1-year follow up. ]
    All cause mortality at 1-year follow up.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with STEMI presenting to a primary reperfusion center in the metropolitan area of Mexico City.
Criteria

Inclusion Criteria:

  • Patients aged 18-99 years old, with the diagnosis of STEMI whom received either PI or PPCI during the first 12 hours since symptom onset. Patients could have a first medical contact directly at the study center or in one of other 60 hospitals along the STEMI network.

Exclusion Criteria:

  • Patients with a discharge diagnosis other than STEMI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974581


Contacts
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Contact: Diego Araiza-Garaygordobil, MD 01 55 5573 2911 dargaray@gmail.com

Locations
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Mexico
Instituto Nacional de Cardiología "Ignacio Chavez" Recruiting
Mexico City, Mexico, 14030
Contact: Diego Araiza-Garaygordobil, MD    5573 2911    diego.araiza@cardiologia.org.mx   
Principal Investigator: Alexandra Arias-Mendoza, MD         
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez

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Responsible Party: Diego Araiza-Garaygordobil, Principal Investigator, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT03974581     History of Changes
Other Study ID Numbers: PT-19-021
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Diego Araiza-Garaygordobil, Instituto Nacional de Cardiologia Ignacio Chavez:
pharmacoinvasive strategy
Mexico
registry

Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases