Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

990 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-08-31

Study Completion Date

2016-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on admission have high rates of mortality (1). The management of hyperglycemic patients during STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients (2).

Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI undergoing quantitative coronary angiography were studied. Patients were categorized in two groups, either treated by thrombus aspiration v/s patients treated without thrombus aspiration. After discharge from the hospital, all patients will be managed and followed quarterly for 12 months month after event, as outpatients, to perform clinical evaluation, routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary disease and heart failure.

Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA before PCI, as compared to hyperglycemic patients treated only by PCI.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Thrombus Aspiration Before Standard Primary Angioplasty Improves Myocardial Reperfusion in Acute Myocardial Infarction.

NCT00257153

Acute Myocardial Infarction

COMPLETED PHASE4

Selective Aspiration Thrombectomy in STEMI

NCT03841487

ST Elevation Myocardial Infarction

COMPLETED

Thrombus Aspiration in Patients With STEMI

NCT02606435

ST-segment Elevation Myocardial Infarction

UNKNOWN PHASE4

Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)

NCT01472718

Primary PCI for STEMI

COMPLETED PHASE4

Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty

NCT02592694

ST-elevation Myocardial Infarction

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The data analyzed in this study will be obtained from hyperglycemic STEMI patients who underwent primary PCI at the Department of Cardiology of the Cardarelli Hospital in Naples Italy between June 1, 2016, and December 1, 2017. This will be a prospective study to compare two therapeutic strategies: PCI plus thrombus aspiration (TA) versus PCI alone in patients with STEMI and hyperglycemia. According to the recent statement by the American Heart Association, hyperglycemia will be defined as an admission plasma glucose level of \>140 mg/dl. Inclusion criteria will include: age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level of \>140 mg/dl. All STEMI patients will be referred to the cardiac catheterization laboratory within 12 h of presentation. Patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting, or had received fibrinolytic therapy will be excluded from the study. The following patients will be referred for urgent invasive diagnostics with the intention of performing PCI: symptom duration of 12 hours or less and ST-segment elevation of 0.1 mV or greater in at least 2 contiguous leads (≥0.2 mV in V1-V3) or presumed new-onset left bundle-branch block. The investigation will be conformed with the principles outlined in the Declaration of Helsinki for use of human tissue or subjects. The Institutional Review Board will approve the protocol.

Outcomes The primary outcome of the THAITI study will be all-cause mortality, cardiovascular deaths, recurrent myocardial infarction, cardiogenic shock, and class IV heart failure within 360 days. Other outcomes will include target vessel revascularisation, stent thrombosis, stroke, and transient ischaemic attack within 360 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hyperglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

STEMI TA hyperglycemic subjects

STEMI hyperglycemic patients, percutaneous coronary intervention with TA

percutaneous coronary intervention

Intervention Type DEVICE

Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.

STEMI without TA hyperglycemic subjects

STEMI hyperglycemic patients, percutaneous coronary intervention without TA

percutaneous coronary intervention

Intervention Type DEVICE

Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

percutaneous coronary intervention

Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- age of 18 years or greater, presentation to the cardiac catheterization laboratory for PCI in the setting of first STEMI, admission plasma glucose level ( \>140 mg/dl in hyperglycemic Group).

Exclusion Criteria

\- patients with left ventricular ejection fraction less than 25%, with previous myocardial infarction or previous PCI or/and coronary by-pass grafting.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No