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Due to insufficient patient inclusion the study has been stopped prematurely.
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| Name | Class |
|---|---|
| Falck Danmark | UNKNOWN |
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The purpose of this study is:
A) To determine whether patients with a certain type of heart attack (NSTEMI) can be reliably diagnosed in an ambulance using telemedicine. This is mandatory if NSTEMI patients in the future are to be treated with acute balloon angioplasty (primary PCI).
B) To evaluate whether primary PCI compared with the current regimen of initial medical stabilization and sub-acute PCI results in reduction of infarct-size in NSTEMI-patients.
Primary PCI versus Traditional Early Invasive Treatment of Patients presenting with NSTEMI
Patients with NSTEMI are currently admitted for initial evaluation and stabilization at local hospitals. An intensive antithrombotic treatment is initiated and after 3 - 7 days of "cooling-off" the patients are referred to an invasive centre for coronary angiography and possibly PCI or CABG - this is known as the early invasive approach. Some of these patients represent a high-risk sub-group with occluded or sub-occluded coronary arteries who might benefit from very early revascularization.
Study Aims
Methods
In this study 300 consecutive patients with symptoms, clinical signs and ECG changes (≥4mm cumulated or ≥ 2mm ST-segment depression (horizontal or descending) in two associated leads) suggesting significant NSTEMI are randomized for one of two strategies, either (A) usual early invasive treatment (coronary angiography and possibly PCI after 3 days) or (B) direct referral (rerouting) to primary PCI at an invasive heart centre (Skejby).
All patients undergo myocardial perfusion imaging at admission for PCI and again after 30 days to estimate AAR, FIS and possible myocardial salvage.
All patients undergo cardiac MRI on the 7th day after admission for determination of AAR and FIS.
The study is a randomized controlled study; it has been approved by the local ethics committee.
Primary outcome measures are specified above
If the study confirms that it is possible to diagnose and re-route NSTEMI patients for primary PCI with an acceptable diagnostic accuracy, then a larger scale mortality study will be planned. Furthermore, the present study will provide valuable information regarding AAR and FIS in NSTEMI-patients which may be of value for planning larger-scale, scintigraphic studies and for the possible future use of a single MRI scan to determine AAR and FIS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Primary PCI in patients with acute Non-STEMI |
|
| 2 | Active Comparator | Standard medical treatment and coronary angiography after 3 days in patients with Non-STEMI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Percutaneous Coronary Intervention | Procedure | Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance. |
| Measure | Description | Time Frame |
|---|---|---|
| Final infarct size in the two study groups determined by MR | On the 7th day after admission |
| Measure | Description | Time Frame |
|---|---|---|
| Scintigraphic Area-At-Risk and Final-Infarct-Size in patients in group A(immediate angioplasty) and group B(early invasive strategy) respectively. | At the time of coronary angiography and after 30 days | |
| Proportion of rerouted patients who are treated with primary PCI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob T Sorensen, MD | Department of Cardiovascular research, Aarhus University Hospital, Skejby | Principal Investigator |
| Hans E Bøtker, MD, DMSc | Department of Cardiovascular research, Aarhus University Hospital, Skejby | Study Director |
| Kristian A Thygesen, MD, DMSc | Department of Cardiovascular research, Aarhus University Hospital, Aarhus Hospital | Study Chair |
| Christian J Terkelsen, MD, PhD | Department of Cardiovascular research, Aarhus University Hospital, Skejby | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiovascular research, Aarhus University Hospital, Skejby | Dk-8200 Aarhus N | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13678918 | Background | De Luca G, Suryapranata H, Zijlstra F, van 't Hof AW, Hoorntje JC, Gosselink AT, Dambrink JH, de Boer MJ; ZWOLLE Myocardial Infarction Study Group. Symptom-onset-to-balloon time and mortality in patients with acute myocardial infarction treated by primary angioplasty. J Am Coll Cardiol. 2003 Sep 17;42(6):991-7. doi: 10.1016/s0735-1097(03)00919-7. | |
| 16513663 |
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|
| Coronary angiography / Percutaneous coronary intervention | Procedure | Coronary Angiography and PCI using standard protocols and guidelines. Contrast either Iomeron or Visipaque at the operators discretion. Equipment used for the PCI is determined at the operators discretion. All patients undergoing primary PCI receive 10.000 units of Heparin, 600 mg of Clopidogrel and a Glycoprotein IIb/IIIa inhibitor. Patients randomized to standard treatment receive 300 mg of Clopidogrel and 120IU/kg of Dalteparin b.i.d until revascularization. Glycoprotein IIb/IIIa inhibitors or thrombin inhibitors can be given as a supplement at the local hospital at the physicians discretion. All patients receive 300 mg of aspirin upon admission or diagnosis in the ambulance. |
|
| At index admission |
| Proportion of patients randomized to immediate angioplasty actually undergoing primary PCI within 120 minutes from first contact to health services. | At index admission |
| Number of readmissions in the two groups due to acute heart failure or reinfarction | 30 days and one year |
| Total number of days admitted at hospital in relation to the index infarction in the two groups | At index admission |
| Total number of days on "sick-leave" in the two groups | In relation to the index admission |
| Evaluation of AAR/FIS obtained by MRI on the 7th day after admission compared to AAR and FIS obtained by myocardial perfusion imaging (scintigraphy). | At the time of coronary angiography, on the 7th day after admission and after 30 days respectively. |
| Boersma E; Primary Coronary Angioplasty vs. Thrombolysis Group. Does time matter? A pooled analysis of randomized clinical trials comparing primary percutaneous coronary intervention and in-hospital fibrinolysis in acute myocardial infarction patients. Eur Heart J. 2006 Apr;27(7):779-88. doi: 10.1093/eurheartj/ehi810. Epub 2006 Mar 2. |
| 11135776 | Background | Magid DJ, Calonge BN, Rumsfeld JS, Canto JG, Frederick PD, Every NR, Barron HV; National Registry of Myocardial Infarction 2 and 3 Investigators. Relation between hospital primary angioplasty volume and mortality for patients with acute MI treated with primary angioplasty vs thrombolytic therapy. JAMA. 2000 Dec 27;284(24):3131-8. doi: 10.1001/jama.284.24.3131. |
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| 11792138 | Background | Spacek R, Widimsky P, Straka Z, Jiresova E, Dvorak J, Polasek R, Karel I, Jirmar R, Lisa L, Budesinsky T, Malek F, Stanka P. Value of first day angiography/angioplasty in evolving Non-ST segment elevation myocardial infarction: an open multicenter randomized trial. The VINO Study. Eur Heart J. 2002 Feb;23(3):230-8. doi: 10.1053/euhj.2001.2735. |
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| 16980115 | Background | Lagerqvist B, Husted S, Kontny F, Stahle E, Swahn E, Wallentin L; Fast Revascularisation during InStability in Coronary artery disease (FRISC-II) Investigators. 5-year outcomes in the FRISC-II randomised trial of an invasive versus a non-invasive strategy in non-ST-elevation acute coronary syndrome: a follow-up study. Lancet. 2006 Sep 16;368(9540):998-1004. doi: 10.1016/S0140-6736(06)69416-6. |
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| 9632444 | Background | Boden WE, O'Rourke RA, Crawford MH, Blaustein AS, Deedwania PC, Zoble RG, Wexler LF, Kleiger RE, Pepine CJ, Ferry DR, Chow BK, Lavori PW. Outcomes in patients with acute non-Q-wave myocardial infarction randomly assigned to an invasive as compared with a conservative management strategy. Veterans Affairs Non-Q-Wave Infarction Strategies in Hospital (VANQWISH) Trial Investigators. N Engl J Med. 1998 Jun 18;338(25):1785-92. doi: 10.1056/NEJM199806183382501. |
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| 14506118 | Background | Neumann FJ, Kastrati A, Pogatsa-Murray G, Mehilli J, Bollwein H, Bestehorn HP, Schmitt C, Seyfarth M, Dirschinger J, Schomig A. Evaluation of prolonged antithrombotic pretreatment ("cooling-off" strategy) before intervention in patients with unstable coronary syndromes: a randomized controlled trial. JAMA. 2003 Sep 24;290(12):1593-9. doi: 10.1001/jama.290.12.1593. |
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| 12930925 | Background | Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003 Aug 21;349(8):733-42. doi: 10.1056/NEJMoa025142. |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D062645 | Percutaneous Coronary Intervention |
| ID | Term |
|---|---|
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
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