Fast Radial Pharmaco-invasive Strategy In ST Elevation Myocardial Infarction Trial

NCT04300582 | Unknown

• 1 other identifier: 001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

INTRODUCTION: The pharmaco-invasive strategy is a safe alternative to primary percutaneous coronary intervention (PCI) in patients with ST elevation acute myocardial infarction, who cannot be in the cathlab in less than 120 minutes. However, previous studies of this strategy used the femoral artery as the main vascular access. Current studies show that the use of the radial artery in cases of acute myocardial infarction minimizes the risk of bleeding and mortality. Therefore, in the scenario where vascular access through the forearm vessels is recommended, the best timing to perform cardiac catheterization in the pharmaco-invasive strategy is not known. OBJECTIVE: To compare the 24-hour hemoglobin drop (acute anemia) between the fast pharmaco-invasive strategy (within 3 hours) and the standard pharmaco-invasive strategy (3 to 24 hours) in patients with acute myocardial infarction (AMI) by coronary occlusion treated in Sancta Maggiore hospitals in São Paulo and underwent to cardiac catheterization through the forearm vessels. METHOD: A prospective, randomized, multicenter study will be conducted in which 120 subjects will be randomly divided for fast and standard cardiac catheterization (1: 1). Stent implantation in the culprit vessel will be performed. The primary objective is to assess whether the fast cardiac catheterization is non-inferior to the standard strategy for a hemoglobin (Hb) drop within 24 hours. Considering in the control group an average drop of Hb 0.6 ± 1g / dl and that a drop greater than 3 g/dL of Hb is related to unfavorable clinical outcome, using a two-tailed alpha of 0.05 and a power of 90% to test the non-inferiority of the fast strategy with respect to standard strategy, each group will require 60 patients, totaling 120 individuals to include. However, if Hb fall in the fast strategy is greater than 3 g/dL and this result does not reproduce in the standard strategy, the study will allow us to show the superiority of the standard approach (between 3 and 24 hours).

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

stemi; thrombolysis; radial approach; acute coronary syndrome; pharmaco-invasive therapy; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• Hemoglobin change

  Mean Hemoglobin change 24 hours after the cardiac catheterization

  24 hours after cardiac catheterization

Secondary Outcomes (18)

• Number of participants with Percutaneous Coronary Intervention failure

  Immediately after percutaneous coronary intervention

• Number of participants with net adverse clinical events (NACE)

  Until hospital discharge, an average of 4 days

• Number of participants with hemoglobin change over 3 g/dL

  24 hours after cardiac catheterization

• Target vessel quantitative flow ratio (QFR) before the percutaneous coronary intervention

  Immediately before the percutaneous coronary

• Target vessel quantitative flow ratio (QFR) after the percutaneous coronary intervention

  Immediately after percutaneous coronary intervention

Study Arms (2)

Standard pharmaco-invasive strategy

ACTIVE COMPARATOR

Cardiac catheterization 3 to 24 hours after thrombolytic completion in STEMI patients.

Procedure: Cardiac catheterization standard strategy

Fast pharmaco-invasive strategy

EXPERIMENTAL

Cardiac catheterization less than 3 hours after thrombolytic completion in STEMI patients.

Procedure: Cardiac catheterization fast strategy

Interventions

Cardiac catheterization standard strategy PROCEDURE

Cardiac catheterization by forearm approach 3 to 24 hours after thrombolytic completion in STEMI patients

Standard pharmaco-invasive strategy

Cardiac catheterization fast strategy PROCEDURE

Cardiac catheterization by forearm approach within 3 hours after thrombolytic completion in STEMI patients

Fast pharmaco-invasive strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ST elevation myocardial infarction
• Submitted to thrombolysis
• Interventional Cardiology Department arrival less than 3 hours after the end of thrombolytic

You may not qualify if:

• Fibrinolytic therapy contraindication: active internal bleeding, clinical signs of acute aortic dissection, traumatic or prolonged cardiopulmonary resuscitation (\> 10 minutes), head trauma in the last four weeks, history of intracranial neoplasia, ischemic stroke in the past year or previous haemorrhagic stroke, pregnancy, sustained severe hypertension (≥180 mmmHg systolic pressure and / or ≥110 mmHg diastolic pressure), trauma or major surgery in the last four weeks, use of oral anticoagulants, history of liver or kidney failure
• No reperfusion criteria when arriving at the Interventional Cardiology Department: no improvement in chest pain or reduction in ST-segment elevation below 50% after thrombolytic administration
• Femoral approach as the first choice for invasive stratification
• Bleeding complications before cardiac catheterization such as important hematoma and stroke
• Acute pulmonary edema: dyspnea of cardiac etiology with increased respiratory effort, hypoxemia and / or desaturation
• Cardiogenic shock: systolic blood pressure below 90 mmHg associated with signs of tissue hypoperfusion, such as oliguria, altered level of consciousness, cyanosis, cold and wet extremities, or vasopressor drug use

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Sancta Maggiore Hospital

São Paulo, 04506000, Brazil

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Bruno Faillace, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carlos Campos, MD, PhD

CONTACT

+5511995006665; carlosacampos1@gmail.com

Rodrigo Esper, MD, PhD

CONTACT

+5511999869306; dresper@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of the fast pharmaco-invasive strategy with the standard pharmaco-invasive strategy in patients with ST-elevation myocardial infarction stratified by the forearm approach

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: March 9, 2020
• Study Start: December 13, 2019
• Primary Completion: July 31, 2021
• Study Completion: August 31, 2021
• Last Updated: March 31, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)