MedTrace Logo

Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction

NCT04043091 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-12

No results posted yet for this study

Summary

Study type: prospective cohort and randomized trial.

Duration: estimated 2 years.

Indications: Type II myocardial infarction in critically ill patients.

Purpose:

1. To recognise the incidence of type I myocardial infarction (MI) in patients with suspected type II MI.
2. Determining the safety of early coronary angiography in this population.
3. Assessment of the effect of percutaneous coronary revascularization in critically ill patients with stable obstructive coronary disease and type II MI.

Hypotheses:

1. Obstructive coronary artery disease suitable for percutaneous revascularization is present in majority of patients with type II MI.
2. Type I MI (acute coronary artery thrombosis) is present in some patients and not recognised.
3. Echocardiogram and a 12-lead electrocardiogram are not reliable in predicting coronary artery disease.
4. Urgent invasive diagnostic is safe in patients with type II MI.
5. Percutaneous revascularization (if indicated) reduces the size of myocardial necrosis in patients with type II MI.

Objectives:

* 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

Interventions

PROCEDURE

percutaneous coronary intervention (stenting)

percutaneous stent implantation in coronary artery

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2021-09-30
Completion
2022-03-31

Countries

  • Slovenia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04043091 on ClinicalTrials.gov