Pharmacoinvasive Strategy vs. Primary PCI in STEMI: A Prospective Registry in a Large Geographical Area

NCT03974581 | Completed DMC

• 1 other identifier: PT-19-021
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction, Acute

Keywords

pharmacoinvasive strategy; Mexico; registry

Outcome Measures

Primary Outcomes (1)

• Composite of cardiovascular mortality + cardiogenic shock + reinfarction + stroke.

  Main efficacy combined outcome including cardiovascular mortality, cardiogenic shock, reinfarction and stroke.

  30-days follow-up.

Secondary Outcomes (2)

• Major bleeding

  Major bleeding during a 30-days follow-up.

• All-cause mortality

  1-year follow up.

Study Arms (2)

Pharmacoinvasive strategy

Patients whom received pharmacoinvasive strategy (fibrinolysis and subsequently PCI) as reperfusion treatment.

Other: Primary percutaneous coronary intervention

Primary PCI

Patients whom primary PCI as reperfusion treatment.

Other: Pharmacoinvasive strategy

Interventions

Primary percutaneous coronary intervention OTHER

Patient receives primary percutaneous coronary intervention as part of his treatment; decision to allocate by treating physician.

Also known as: Primary PCI

Pharmacoinvasive strategy

Pharmacoinvasive strategy OTHER

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 PCI

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with STEMI presenting to a primary reperfusion center in the metropolitan area of Mexico City.

You may qualify if:

• 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.

You may not qualify if:

• Patients with a discharge diagnosis other than STEMI.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiología "Ignacio Chavez"

Mexico City, 14030, Mexico

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 5, 2019
• Study Start: April 30, 2018
• Primary Completion: July 14, 2020
• Study Completion: July 14, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

ME (1)