Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction

NCT04043091 | Withdrawn

• 1 other identifier: CIIM_MI2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Study type: prospective cohort and randomized trial. Duration: estimated 2 years. Indications: Type II myocardial infarction in critically ill patients. Purpose:

• Primary endpoint: to demonstrate that percutaneous coronary intervention (PCI) in the group with obstructive coronary disease reduces the size of MI.
• Secondary endpoints: improved cardiac function after revascularization, shorter hospitalization, reduced mortality.
• Safety objective: renal function, bleeding complications. Population: 140 patients with type II MI over 18 years of age with no evidence of active bleeding. Inclusion criteria:
• age\> 18 years
• High sensitive troponin I \> 40 ng / L for women and \> 58ng / L for men
• Critical illness (at least one vital organ support)
• Imaging signs (electrocardiogram or ultrasound) signs of myocardial ischemia Exclusion criteria:
• active bleeding
• terminal illness Monitoring of patients: during hospitalization, 30 days after discharge, 6 months after discharge. Performance check:
• PCI success (% of "thrombolysis in myocardial infarction" flow 3)
• the size of MI (troponin area under the curve)
• left ventricular ejection fraction
• hospital stay
• 30 day survival Safety Check:
• monitoring of renal function
• monitoring of bleeding complications
• monitoring of allergic reactions to contrast and medication Patient Consent: written informed consent for inclusion in the study in conscious population. In unconscious patients, written consent will be obtained in the event of mental function improvement.

Conditions

Type 2 Myocardial Infarction; Coronary Artery Disease; Percutaneous Coronary Intervention; Critical Illness

Keywords

Type 2 myocardial infarction; Percutaneous Coronary Intervention; Critical Illness

Outcome Measures

Primary Outcomes (1)

• extent of myocardial necrosis

  troponin I hs area under the curve

  3 days

Secondary Outcomes (3)

• ICU stay

  30 days

• survival

  30 days

• Left ventricular systolic function

  5 days

Study Arms (2)

percutaneous coronary intervention

EXPERIMENTAL

stable obstructive coronary artery disease (coronary artery stenosis \>70%) - percutaneous coronary intervention performed in all diseased segments until 300 mL of contrast reached; preferably with drug eluting stents; along with standard medical therapy

Procedure: percutaneous coronary intervention (stenting)

standard of care

NO INTERVENTION

stable obstructive coronary artery disease (coronary artery stenosis \>70%) - no intervention (revascularization), just standard medical therapy

Interventions

percutaneous coronary intervention (stenting) PROCEDURE

percutaneous stent implantation in coronary artery

percutaneous coronary intervention

Eligibility Criteria

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

You may qualify if:

• age \> 18 years
• High sensitive troponin I \> 40 ng / L for women and \> 58ng / L for men
• Critical illness (at least one vital organ support)
• Imaging signs (ECG or ultrasound) signs of myocardial ischemia

You may not qualify if:

• active bleeding
• terminal illness

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1525, Slovenia

Location

Related Publications (2)

• Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

  PMID: 26320110 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). Glob Heart. 2018 Dec;13(4):305-338. doi: 10.1016/j.gheart.2018.08.004. Epub 2018 Aug 25. No abstract available.

  PMID: 30154043 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Critical Illness

Interventions

Percutaneous Coronary Intervention; Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist.prof. Peter Radsel, MD, PhD

Model Details: randomization in 2 groups

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 2, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

SL (1)