A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI (TOTAL)
This study is currently recruiting participants.
Verified May 2013 by Population Health Research Institute
Sponsor:
Population Health Research Institute
Information provided by (Responsible Party):
Dr. Sanjit S. Jolly, Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01149044
First received: June 22, 2010
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome ST Elevation Myocardial Infarction Percutaneous Coronary Intervention |
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI |
Resource links provided by NLM:
Further study details as provided by Population Health Research Institute:
Primary Outcome Measures:
- The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Stroke [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
- Key Net Benefit Outcome: CV death, MI, stroke, cardiogenic shock or new or worsening NHYA Class IV heart failure [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
- Cardiovascular Mortality [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Primary outcome at 30 days and 1 year [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Components of primary outcome [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]CV death, MI, cardiogenic shock or new or worsening class IV heart failure assessed separately at 30 days, 180 days and one year
- All-cause mortality [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]All-cause mortality at 30 days, 180 days and 1 year
- Composite of CV death, MI, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days [ Time Frame: up to 180 days ] [ Designated as safety issue: No ]Composite of cardiovascular death, myocardial infarction, cardiogenic shock, or new or worsening NYHA class IV heart failure at 30 days, 180 days
- TIMI flow rates, no reflow [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Stent thrombosis [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Distal embolization [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Left main thrombus as a complication of the PCI procedure [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Target Vessel dissection [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Left main dissection [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Major Bleeding [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 6000 |
| Study Start Date: | August 2010 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Upfront Thrombectomy followed by PCI
Upfront manual aspiration thrombectomy followed by PCI
|
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy |
|
Active Comparator: PCI Alone
PCI without upfront manual aspiration thrombectomy
|
Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy |
Detailed Description:
The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing primary PCI.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients presenting with:
- Symptoms of myocardial ischemia lasting for ≥ 30 minutes AND
- Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
- Referred for primary PCI
- Randomized within 12 hours of symptoms onset and prior to diagnostic angiography
- Informed consent
Exclusion Criteria:
- Age ≤ 18 years
- Prior coronary artery bypass surgery (CABG)
- Life expectancy less than six months due to non-cardiac condition
- Treatment with fibrinolytic therapy for qualifying index STEMI event
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01149044
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Contacts
| Contact: Brandi L Meeks, M.Eng. | 905 527 4322 ext 40442 | total@phri.ca |
Hide Study LocationsLocations
| United States, Georgia | |
| Emory University Hospital Midtown | Active, not recruiting |
| Atlanta, Georgia, United States | |
| United States, New Mexico | |
| University of New Mexico Health Sciences Center | Active, not recruiting |
| Albuquerque, New Mexico, United States | |
| United States, Ohio | |
| Lindner Research Center at Christ Hospital | Recruiting |
| Cincinnati, Ohio, United States | |
| Contact: Dr. I. Sarembock total@phri.ca | |
| United States, Pennsylvania | |
| Geisinger Clinic | Active, not recruiting |
| Danville, Pennsylvania, United States | |
| WPAHS - Allegheny General Hospital | Active, not recruiting |
| Pittsburgh, Pennsylvania, United States | |
| Northeast Clinical Trials Group | Recruiting |
| Scranton, Pennsylvania, United States | |
| Contact: Dr. S. Pancholy total@phri.ca | |
| Australia, New South Wales | |
| Royal North Shore Hospital | Recruiting |
| Sydney, New South Wales, Australia | |
| Contact: Dr. R. Bhindi total@phri.ca | |
| St. George Public Hospital | Recruiting |
| Sydney, New South Wales, Australia | |
| Contact: Dr. J. Weaver total@phri.ca | |
| Brazil | |
| Hospital Sao Lucas - PUCRS | Recruiting |
| Porto Alegre, RS, Brazil | |
| Contact: Dr. P. Caramori total@phri.ca | |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Recruiting |
| Porto Alegre, RS, Brazil | |
| Contact: Dr. V. Lima total@phri.ca | |
| Hospital Santa Isabel | Recruiting |
| Blumenau, Santa Catarina, Brazil | |
| Contact: Dr. A. Kormann total@phri.ca | |
| Santa Casa de Marilia | Recruiting |
| Marilia, Sao Paulo, Brazil | |
| Contact: Dr. M.A. Tebet total@phri.ca | |
| Fundação Faculdade de Medicina de São José do Rio Preto | Recruiting |
| Sao Jose do Rio Preto, Sao Paulo, Brazil | |
| Contact: Dr. M.A. dos Santos total@phri.ca | |
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Dr. R. Welsh total@phri.ca | |
| Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada | |
| Contact: Dr. R. Leung total@phri.ca | |
| Canada, British Columbia | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Dr. A. Fung total@phri.ca | |
| Victoria Heart Institute | Recruiting |
| Victoria, British Columbia, Canada | |
| Contact: Dr. A. Della Siega total@phri.ca | |
| Royal Columbian Hospital | Recruiting |
| Westminster, British Columbia, Canada | |
| Contact: Dr. J. Charania total@phri.ca | |
| Canada, Nova Scotia | |
| Queen Elizabeth II Health Sciences | Recruiting |
| Halifax, Nova Scotia, Canada | |
| Contact: Dr. S.N. Nadeem total@phri.ca | |
| Canada, Ontario | |
| Hamilton General Hospital | Recruiting |
| Hamilton, Ontario, Canada, L8L 2X2 | |
| Contact: Dr. S. Jolly total@phri.ca | |
| London Health Sciences Centre | Recruiting |
| London, Ontario, Canada | |
| Contact: Dr. S. Lavi total@phri.ca | |
| York PCI Group - Southlake Regional | Recruiting |
| Newmarket, Ontario, Canada | |
| Contact: Dr. W. Cantor total@phri.ca | |
| Scarborough Cardiology Research | Recruiting |
| Scarborough, Ontario, Canada | |
| Contact: Dr. S. Kassam total@phri.ca | |
| St. Michael's Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Dr. A. Cheema total@phri.ca | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Dr. V. Dzavik total@phri.ca | |
| Canada, Quebec | |
| CSSS de Chicoutimi | Recruiting |
| Chicoutimi, Quebec, Canada | |
| Contact: Dr. T. Cieza total@phri.ca | |
| MUHC Royal Victoria Hospital | Recruiting |
| Montreal, Quebec, Canada | |
| Contact: Dr. L. Bilodeau total@phri.ca | |
| Quebec Heart Lung Insitute | Recruiting |
| Quebec City, Quebec, Canada | |
| Contact: Dr. O. Bertrand total@phri.ca | |
| China | |
| The Tenth People's Hospital Tongji University | Recruiting |
| Shanghai, China | |
| Contact: Prof. Y. Xu total@phri.ca | |
| Shanghai Gongli Hospital | Recruiting |
| Shanghai, China | |
| Contact: Dr. J. Qiu total@phri.ca | |
| Yueyang Hospital Shanghai University of TCM | Recruiting |
| Shanghai, China | |
| Contact: Dr. H. Luo total@phri.ca | |
| The First People's Hospital, Jiatong University | Recruiting |
| Shanghai, China | |
| Contact: Dr. S. Liu total@phri.ca | |
| Czech Republic | |
| Krasjska Nemocnice Liberec | Recruiting |
| Liberec, Czech Republic | |
| Contact: Dr. D. Horak total@phri.ca | |
| University Hospital Pilsen | Recruiting |
| Pilsen, Czech Republic | |
| Contact: Dr. I. Bernat total@phri.ca | |
| University Hospital Motol | Recruiting |
| Prague, Czech Republic | |
| Contact: Dr. P. Hajek total@phri.ca | |
| University Hospital Kralovske Vinohrady | Recruiting |
| Praha, Czech Republic | |
| Contact: Dr. V. Kocka total@phri.ca | |
| Masaryk Hospital | Active, not recruiting |
| Usti nad Labem, Czech Republic | |
| Finland | |
| Kuopio University Hospital | Recruiting |
| Kuopio, Finland | |
| Contact: Dr. H. Romppanen total@phri.ca | |
| Heart Center, Tampere University Hospital | Recruiting |
| Tampere, Finland | |
| Contact: Prof. K. Niemela total@phri.ca | |
| France | |
| CHU Albert Michallon | Recruiting |
| Grenoble, France | |
| Contact: Dr. S. Marliere total@phri.ca | |
| Hopital Universitaire Nord Marseille | Recruiting |
| Marseille, France | |
| Contact: Dr. L. Bonello total@phri.ca | |
| Hopital Lariboisiere Ap-HP | Recruiting |
| Paris, France | |
| Contact: Dr. G. Sideris total@phri.ca | |
| Hopital Bichat | Recruiting |
| Paris, France | |
| Contact: Prof. P.G. Steg total@phri.ca | |
| Centre Hospitalier de Pau | Recruiting |
| Pau, France | |
| Contact: Dr. N. Delarche total@phri.ca | |
| Germany | |
| Elisabeth-Krankenhaus Essen | Recruiting |
| Essen, Germany | |
| Contact: Dr. C. Naber total@phri.ca | |
| Clinical Association Oberallgaeu-Kempten | Recruiting |
| Immenstadt, Germany | |
| Contact: Prof. J. Torzewski total@phri.ca | |
| Greece | |
| Patras University Hospital | Recruiting |
| Patras, Greece | |
| Contact: Prof. D. Alexopoulos total@phri.ca | |
| Ahepa University Hospital | Recruiting |
| Thessaloniki, Greece | |
| Contact: Dr. A. Ziakas total@phri.ca | |
| Hungary | |
| Semmelweis University Heart and Vascular Center | Recruiting |
| Budapest, Hungary | |
| Contact: Prof. B. Merkely | |
| University of Szeged | Recruiting |
| Szeged, Hungary | |
| Contact: Prof. I. Ungi total@phri.ca | |
| Korea, Republic of | |
| Soonchunhyang University Cheonan Hospital | Recruiting |
| Cheonan, Korea, Republic of | |
| Contact: Dr. Seung Jin Lee total@phri.ca | |
| Chonnam National University Hospital | Recruiting |
| Gwangju, Korea, Republic of | |
| Contact: Dr. Myung-Ho Jeong total@phri.ca | |
| Kyung-Hee University Hospital | Recruiting |
| Seoul, Korea, Republic of | |
| Contact: Prof. Weon Kim total@phri.ca | |
| Macedonia, The Former Yugoslav Republic of | |
| Medical University Skopje | Recruiting |
| Skopje, Macedonia, The Former Yugoslav Republic of | |
| Contact: Prof. S. Kedev total@phri.ca | |
| Netherlands | |
| St. Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: Prof. J.M. ten Berg total@phri.ca | |
| Serbia | |
| Clinical Center of Serbia | Recruiting |
| Belgrade, Serbia | |
| Contact: Prof. G. Stankovic total@phri.ca | |
| Spain | |
| Hospital Universitari Germans Trias I Pujol | Recruiting |
| Baldona, Spain | |
| Contact: Dr. J. Mauri total@phri.ca | |
| Hospital Universitari de Bellvitge | Recruiting |
| Barcelona, Spain | |
| Contact: Prof. A. Cequier total@phri.ca | |
| Complexo Hospitalario A Coruna | Recruiting |
| Barcelona, Spain | |
| Contact: Dr. N. Vazquez total@phri.ca | |
| Hospital Vall d'Hebron | Recruiting |
| Barcelona, Spain | |
| Contact: Dr. B. Garcia del Blanco total@phri.ca | |
| University Hospital La Paz | Recruiting |
| Madrid, Spain | |
| Contact: Dr. R. Moreno Gomez total@phri.ca | |
| Hospital Universitario Virgen de la Victoria | Recruiting |
| Malaga, Spain | |
| Contact: Dr. J.M. Hernandez total@phri.ca | |
| Hospital Son Espases | Recruiting |
| Palma de Mallorca, Spain | |
| Contact: Dr. A. Bethencourt total@phri.ca | |
| Hospital Clinico Universitario de Vigo | Recruiting |
| Vigo, Spain | |
| Contact: Dr. A. Iniguez Romo total@phri.ca | |
| United Kingdom | |
| Hull and East Yorkshire Hospitals | Recruiting |
| Hull, United Kingdom | |
| Contact: Dr. S. Thackray total@phri.ca | |
| Glenfield General Hospital | Recruiting |
| Leicester, United Kingdom | |
| Contact: Prof. A. Gershlick total@phri.ca | |
| Manchester Royal Infirmary | Recruiting |
| Manchester, United Kingdom | |
| Contact: Dr. M. El-Omar total@phri.ca | |
| Sheffield Teaching Hospitals | Recruiting |
| Sheffield, United Kingdom | |
| Contact: Dr. J. Gunn total@phri.ca | |
| Musgrove Park Hospital | Recruiting |
| Taunton, United Kingdom | |
| Contact: Dr. M. Seddon total@phri.ca | |
Sponsors and Collaborators
Population Health Research Institute
Investigators
| Principal Investigator: | Sanjit S. Jolly, MD, MSc, FRCP | Hamilton Health Sciences Corporation |
| Principal Investigator: | Vladimir Džavík, MD, FRCPC | Peter Munk Cardiac Centre, University Health Network |
More Information
Additional Information:
No publications provided by Population Health Research Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Sanjit S. Jolly, MD MSc, FRCP(C), Interventional Cardiologist, Assistant Professor, Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01149044 History of Changes |
| Other Study ID Numbers: | TOTAL Trial |
| Study First Received: | June 22, 2010 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Canada: Research Ethics Board United States: Institutional Review Board Macedonia: Ethics Committee Brazil: Ethics Committee China: Ethics Committee Czech Republic: Ethics Committee Finland: Ethics Committee Australia: Ethics Committee Serbia: Ethics Committee Greece: Ethics Committee France: Ethics Committee Germany: Ethics Committee Hungary: Ethics Committee Netherlands: Ethics Committee South Korea: Ethics Committee Spain: Ethics Committee United Kingdom: Ethics Committee |
Keywords provided by Population Health Research Institute:
|
Acute Coronary Syndrome PCI Percutaneous Coronary Intervention STEMI Thrombectomy |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Acute Coronary Syndrome Ischemia Pathologic Processes Necrosis Myocardial Ischemia |
Heart Diseases Cardiovascular Diseases Vascular Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013