Trhombus Aspiration in Hyperglycemic ST-elevation myocardiAl InfarcTIon

NCT02817542 | Completed

• 1 other identifier: TAHITI
• Study Type: observational
• Target: 990
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia

Outcome Measures

Primary Outcomes (4)

• cardiovascular death

  death caused by loss of heart function such as sudden cardiac arrest or heart attack (myocardial infarction). ECG and cardiac damage markers

  12 months

• recurrent myocardial infarction

  Myocardial infarction when there is a blockage in one or more of the arteries to the heart, preventing the heart from receiving enough oxygen-rich blood. If the oxygen in the blood cannot reach the heart muscle, the heart becomes damaged. ECG and cardiac damage markers

  12 months

• heart failure.

  Heart failure develops when the heart, via an abnormality of cardiac function (detectable or not), fails to pump blood at a rate commensurate with the requirements of the metabolizing tissues or is able to do so only with an elevated diastolic filling pressure. ECG and echocardiography

  12 months

• acute coronary syndrome

  non-ST-elevation acute coronary syndromes (ACSs) and unstable angina. ECG and cardiac damage markers

  12 months

Secondary Outcomes (4)

• Target vessel revascularisation

  12 months

• stent thrombosis,

  12 months

• stroke

  12 months

• transient ischaemic attack

  12 months

Study Arms (2)

STEMI TA hyperglycemic subjects

STEMI hyperglycemic patients, percutaneous coronary intervention with TA

Device: percutaneous coronary intervention

STEMI without TA hyperglycemic subjects

STEMI hyperglycemic patients, percutaneous coronary intervention without TA

Device: percutaneous coronary intervention

Interventions

percutaneous coronary intervention 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 TA hyperglycemic subjects; STEMI without TA hyperglycemic subjects

Eligibility Criteria

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

Study Population

We will analyze the consecutive patients presenting with acute myocardial infarction and ST segment elevation (STEMI) admitted to the Department of Cardiology of the Cardarelli Hospital in Naples, Italy. 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 ( \>140 mg/dl in hyperglycemic Group). 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 will be excluded.

You may qualify if:

• \- 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

Cardarelli Hospital

Naples, Italy, 80100, Italy

Location

Related Publications (4)

• Jones DA, Rathod KS, Gallagher S, Jain AK, Kalra SS, Lim P, Crake T, Ozkor M, Rakhit R, Knight CJ, Iqbal MB, Dalby MC, Malik IS, Whitbread M, Mathur A, Redwood S, MacCarthy PA, Weerackody R, Wragg A. Manual Thrombus Aspiration Is Not Associated With Reduced Mortality in Patients Treated With Primary Percutaneous Coronary Intervention: An Observational Study of 10,929 Patients With ST-Segment Elevation Myocardial Infarction From the London Heart Attack Group. JACC Cardiovasc Interv. 2015 Apr 20;8(4):575-84. doi: 10.1016/j.jcin.2014.11.021.

  PMID: 25907084 RESULT

• Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P; American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Circulation. 2008 Mar 25;117(12):1610-9. doi: 10.1161/CIRCULATIONAHA.107.188629. Epub 2008 Feb 25.

  PMID: 18299505 RESULT

• Tilsted HH, Olivecrona GK. To Aspirate or Not to Aspirate: That Is the Question. JACC Cardiovasc Interv. 2015 Apr 20;8(4):585-7. doi: 10.1016/j.jcin.2015.01.014. No abstract available.

  PMID: 25907085 RESULT

• Sardu C, Barbieri M, Balestrieri ML, Siniscalchi M, Paolisso P, Calabro P, Minicucci F, Signoriello G, Portoghese M, Mone P, D'Andrea D, Gragnano F, Bellis A, Mauro C, Paolisso G, Rizzo MR, Marfella R. Thrombus aspiration in hyperglycemic ST-elevation myocardial infarction (STEMI) patients: clinical outcomes at 1-year follow-up. Cardiovasc Diabetol. 2018 Nov 29;17(1):152. doi: 10.1186/s12933-018-0795-8.

  PMID: 30497513 DERIVED

MeSH Terms

Conditions

Hyperglycemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Celestino Sardu, MD, PHD

  University of Campania Luigi Vanvitelli

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal medicine full professor

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: June 29, 2016
• Study Start: August 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: February 15, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)