Myocardial InfarctionDaNSTEMI2NCT00493584
Acute Balloon Angioplasty vs. Traditional Early Invasive Treatment of Non-ST-Elevation Myocardial Infarction
A study testing Primary Percutaneous Coronary Intervention and Coronary angiography / Percutaneous coronary intervention in people with Myocardial Infarction, run by University of Aarhus at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Primary Percutaneous Coronary Intervention and Coronary angiography / Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2008to Mar 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with symptoms and signs of NSTEMI and significant ECG changes (Either ≥4mm cumulated ST-segment depression (horizontal or descending), or ≥2mm ST-segment depression (horizontal or descending) in two associated leads)and/or patients with positive biomarkers for myocardial infarction (troponin T) measured in the ambulance (prehospital measurement of biomarkers).
- Age above 18 years.
- Tentative diagnosis made pre-hospitally.
Who cannot join
- Severe mental or psychiatric disease (eg. psychosis, dementia, bipolar disorder or depression) as well as other conditions making it impossible to obtain informed consent.
- Prior CABG (Coronary artery bypass graft) operation.
- Patients with ST-depression presumed to be caused by tachycardia or cardiac hypertrophy.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiovascular research, Aarhus University Hospital, Skejby
Dk-8200 Aarhus N
About this study
Official title: Acute Angioplasty (Primary PCI) Versus Traditional Early Invasive Treatment of Patients Presenting With NSTEMI (The Second Danish Non-ST-Elevation MI Trial - DaNSTEMI-2)
The purpose of this study is:
- 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).
- 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.
Read the detailed description
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
- To investigate if it is technically feasible to diagnose patients with NSTEMI in the pre-hospital setting and reroute them to an invasive heart centre for primary PCI in a timely manner.
- To estimate area at risk (AAR = the part of cardiac muscle tissue at risk of infarction) and final infarct size (FIS) in patients referred for primary PCI and patients undergoing the traditional "early invasive" treatment, respectively.
- To investigate whether Primary PCI in patients with NSTEMI results in a shorter duration of the primary admission, fewer rehospitalizations with reinfarction and acute heart failure and a briefer overall "sick leave" within a year from the index admission.
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.
- Conditions
- Myocardial Infarction
- Being tested
- Primary Percutaneous Coronary Intervention, Coronary angiography / Percutaneous coronary intervention
- Keywords
- Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Telemedicine, Percutaneous Transluminal Coronary Angioplasty
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous Coronary InterventionProcedure or surgery
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.
Coronary angiography / Percutaneous coronary interventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Primary PCI in patients with acute Non-STEMI Receives: Procedure: Primary Percutaneous Coronary Intervention |
| 2 | Active comparator | Standard medical treatment and coronary angiography after 3 days in patients with Non-STEMI. Receives: Procedure: Coronary angiography / Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final infarct size in the two study groups determined by MR
Measured: On the 7th day after admission
Secondary outcomes (7)
Scintigraphic Area-At-Risk and Final-Infarct-Size in patients in group A(immediate angioplasty) and group B(early invasive strategy) respectively.
Measured: At the time of coronary angiography and after 30 days
Proportion of rerouted patients who are treated with primary PCI.
Measured: At index admission
Proportion of patients randomized to immediate angioplasty actually undergoing primary PCI within 120 minutes from first contact to health services.
Measured: At index admission
Number of readmissions in the two groups due to acute heart failure or reinfarction
Measured: 30 days and one year
Total number of days admitted at hospital in relation to the index infarction in the two groups
Measured: At index admission
Total number of days on "sick-leave" in the two groups
Measured: 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).
Measured: At the time of coronary angiography, on the 7th day after admission and after 30 days respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startMar 2008
- Primary completionMar 2011 (estimated)
- Study completionMar 2011 (estimated)
Why it stopped: Due to insufficient patient inclusion the study has been stopped prematurely.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Falck Danmark
- Investigators
- Jacob T Sorensen, MD, Principal investigator, Department of Cardiovascular research, Aarhus University Hospital, SkejbyHans E Bøtker, MD, DMSc, Study director, Department of Cardiovascular research, Aarhus University Hospital, SkejbyKristian A Thygesen, MD, DMSc, Study chair, Department of Cardiovascular research, Aarhus University Hospital, Aarhus HospitalChristian J Terkelsen, MD, PhD, Study chair, Department of Cardiovascular research, Aarhus University Hospital, Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493584
- Sponsor's protocol ID
- Thorsted 1
- Acronym
- DaNSTEMI2
- Status last verified
- May 2009
- First submitted
- 27 Jun 2007
- Last updated
- 20 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 13678918Boersma 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.
PubMed 16513663Magid 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.
PubMed 11135776Terkelsen CJ, Lassen JF, Norgaard BL, Gerdes JC, Poulsen SH, Bendix K, Ankersen JP, Gotzsche LB, Romer FK, Nielsen TT, Andersen HR. Reduction of treatment delay in patients with ST-elevation myocardial infarction: impact of pre-hospital diagnosis and direct referral to primary percutanous coronary intervention. Eur Heart J. 2005 Apr;26(8):770-7. doi: 10.1093/eurheartj/ehi100. Epub 2005 Jan 31.
PubMed 15684279Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on the management of patients with unstable angina). Circulation. 2000 Sep 5;102(10):1193-209. doi: 10.1161/01.cir.102.10.1193. No abstract available.
PubMed 10973852Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, De Feyter PJ, Specchia G, Ruzyllo W; Task Force on the Management of Acute Coronary Syndromes of the European Society of Cardiology. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2002 Dec;23(23):1809-40. doi: 10.1053/euhj.2002.3385. No abstract available.
PubMed 12503543Terkelsen CJ, Lassen JF, Norgaard BL, Gerdes JC, Jensen T, Gotzsche LB, Nielsen TT, Andersen HR. Mortality rates in patients with ST-elevation vs. non-ST-elevation acute myocardial infarction: observations from an unselected cohort. Eur Heart J. 2005 Jan;26(1):18-26. doi: 10.1093/eurheartj/ehi002. Epub 2004 Nov 23.
PubMed 15615795Koyama Y, Hansen PS, Hanratty CG, Nelson GI, Rasmussen HH. Prevalence of coronary occlusion and outcome of an immediate invasive strategy in suspected acute myocardial infarction with and without ST-segment elevation. Am J Cardiol. 2002 Sep 15;90(6):579-84. doi: 10.1016/s0002-9149(02)02559-6.
PubMed 12231080Spacek 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.
PubMed 11792138Fox KA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TR, Wheatley DJ, Pocock SJ; Randomized Intervention Trial of unstable Angina Investigators. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina. Lancet. 2002 Sep 7;360(9335):743-51. doi: 10.1016/s0140-6736(02)09894-x.
PubMed 12241831Lagerqvist 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.
PubMed 16980115de Winter RJ, Windhausen F, Cornel JH, Dunselman PH, Janus CL, Bendermacher PE, Michels HR, Sanders GT, Tijssen JG, Verheugt FW; Invasive versus Conservative Treatment in Unstable Coronary Syndromes (ICTUS) Investigators. Early invasive versus selectively invasive management for acute coronary syndromes. N Engl J Med. 2005 Sep 15;353(11):1095-104. doi: 10.1056/NEJMoa044259.
PubMed 16162880Boden 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.
PubMed 9632444Hoenig MR, Doust JA, Aroney CN, Scott IA. Early invasive versus conservative strategies for unstable angina & non-ST-elevation myocardial infarction in the stent era. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD004815. doi: 10.1002/14651858.CD004815.pub2.
PubMed 16856061Breeman A, Ottervanger JP, Boersma E, De Luca G. Coronary revascularization for non-ST elevation acute coronary syndrome: state of the art. J Cardiovasc Med (Hagerstown). 2006 Feb;7(2):108-13. doi: 10.2459/01.JCM.0000203185.66608.2f.
PubMed 16645369
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Angioplasty (Primary PCI) Versus Traditional Early Invasive Treatment of Patients Presenting With NSTEMI (The Second Danish Non-ST-Elevation MI Trial - DaNSTEMI-2)
- ClinicalTrials.gov ID
- NCT00493584
- Acronym / sponsor ID
- DaNSTEMI2 / Thorsted 1
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Telemedicine, Percutaneous Transluminal Coronary Angioplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to insufficient patient inclusion the study has been stopped prematurely.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Falck Danmark
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (estimated)
- Study completion
- Mar 2011 (estimated)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- 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).
- 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.
Detailed description
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
- To investigate if it is technically feasible to diagnose patients with NSTEMI in the pre-hospital setting and reroute them to an invasive heart centre for primary PCI in a timely manner.
- To estimate area at risk (AAR = the part of cardiac muscle tissue at risk of infarction) and final infarct size (FIS) in patients referred for primary PCI and patients undergoing the traditional "early invasive" treatment, respectively.
- To investigate whether Primary PCI in patients with NSTEMI results in a shorter duration of the primary admission, fewer rehospitalizations with reinfarction and acute heart failure and a briefer overall "sick leave" within a year from the index admission.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Primary Percutaneous Coronary InterventionPrimary PCI in patients with acute Non-STEMI |
| 2 | Active comparator | Procedure: Coronary angiography / Percutaneous coronary interventionStandard medical treatment and coronary angiography after 3 days in patients with Non-STEMI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with symptoms and signs of NSTEMI and significant ECG changes (Either ≥4mm cumulated ST-segment depression (horizontal or descending), or ≥2mm ST-segment depression (horizontal or descending) in two associated leads)and/or patients with positive biomarkers for myocardial infarction (troponin T) measured in the ambulance (prehospital measurement of biomarkers).
- Age above 18 years.
- Tentative diagnosis made pre-hospitally.
Key exclusion criteria (3 listed)
- Severe mental or psychiatric disease (eg. psychosis, dementia, bipolar disorder or depression) as well as other conditions making it impossible to obtain informed consent.
- Prior CABG (Coronary artery bypass graft) operation.
- Patients with ST-depression presumed to be caused by tachycardia or cardiac hypertrophy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Percutaneous Coronary InterventionCoronary 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. | Procedure or surgery | 1 |
| Coronary angiography / Percutaneous coronary interventionCoronary 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. | Procedure or surgery | 2 |
Primary outcome
Final infarct size in the two study groups determined by MR
Time frame: On the 7th day after admission
7 secondary outcomes
Scintigraphic Area-At-Risk and Final-Infarct-Size in patients in group A(immediate angioplasty) and group B(early invasive strategy) respectively.
Time frame: At the time of coronary angiography and after 30 days
Proportion of rerouted patients who are treated with primary PCI.
Time frame: At index admission
Proportion of patients randomized to immediate angioplasty actually undergoing primary PCI within 120 minutes from first contact to health services.
Time frame: At index admission
Number of readmissions in the two groups due to acute heart failure or reinfarction
Time frame: 30 days and one year
Total number of days admitted at hospital in relation to the index infarction in the two groups
Time frame: At index admission
Total number of days on "sick-leave" in the two groups
Time frame: 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).
Time frame: At the time of coronary angiography, on the 7th day after admission and after 30 days respectively.
Results and safety
The study was stopped early (reason given: Due to insufficient patient inclusion the study has been stopped prematurely.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2009.
- Background: PubMed 13678918De 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.
- Background: PubMed 16513663Boersma 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.
- Background: PubMed 11135776Magid 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.
- Background: PubMed 15684279Terkelsen CJ, Lassen JF, Norgaard BL, Gerdes JC, Poulsen SH, Bendix K, Ankersen JP, Gotzsche LB, Romer FK, Nielsen TT, Andersen HR. Reduction of treatment delay in patients with ST-elevation myocardial infarction: impact of pre-hospital diagnosis and direct referral to primary percutanous coronary intervention. Eur Heart J. 2005 Apr;26(8):770-7. doi: 10.1093/eurheartj/ehi100. Epub 2005 Jan 31.
- Background: PubMed 10973852Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC Jr. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction: executive summary and recommendations. A report of the American College of Cardiology/American Heart Association task force on practice guidelines (committee on the management of patients with unstable angina). Circulation. 2000 Sep 5;102(10):1193-209. doi: 10.1161/01.cir.102.10.1193. No abstract available.
- Background: PubMed 12503543Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, De Feyter PJ, Specchia G, Ruzyllo W; Task Force on the Management of Acute Coronary Syndromes of the European Society of Cardiology. Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2002 Dec;23(23):1809-40. doi: 10.1053/euhj.2002.3385. No abstract available.
- Background: PubMed 15615795Terkelsen CJ, Lassen JF, Norgaard BL, Gerdes JC, Jensen T, Gotzsche LB, Nielsen TT, Andersen HR. Mortality rates in patients with ST-elevation vs. non-ST-elevation acute myocardial infarction: observations from an unselected cohort. Eur Heart J. 2005 Jan;26(1):18-26. doi: 10.1093/eurheartj/ehi002. Epub 2004 Nov 23.
- Background: PubMed 12231080Koyama Y, Hansen PS, Hanratty CG, Nelson GI, Rasmussen HH. Prevalence of coronary occlusion and outcome of an immediate invasive strategy in suspected acute myocardial infarction with and without ST-segment elevation. Am J Cardiol. 2002 Sep 15;90(6):579-84. doi: 10.1016/s0002-9149(02)02559-6.
- Background: PubMed 11792138Spacek 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.
- Background: PubMed 12241831Fox KA, Poole-Wilson PA, Henderson RA, Clayton TC, Chamberlain DA, Shaw TR, Wheatley DJ, Pocock SJ; Randomized Intervention Trial of unstable Angina Investigators. Interventional versus conservative treatment for patients with unstable angina or non-ST-elevation myocardial infarction: the British Heart Foundation RITA 3 randomised trial. Randomized Intervention Trial of unstable Angina. Lancet. 2002 Sep 7;360(9335):743-51. doi: 10.1016/s0140-6736(02)09894-x.
- Background: PubMed 16980115Lagerqvist 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob T Sorensen, MD principal investigator
Department of Cardiovascular research, Aarhus University Hospital, Skejby
Hans E Bøtker, MD, DMSc study director
Department of Cardiovascular research, Aarhus University Hospital, Skejby
Kristian A Thygesen, MD, DMSc study chair
Department of Cardiovascular research, Aarhus University Hospital, Aarhus Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Percutaneous Coronary Intervention and Coronary angiography / Percutaneous coronary intervention in people with Myocardial Infarction, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to insufficient patient inclusion the study has been stopped prematurely.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final infarct size in the two study groups determined by MR (time frame: On the 7th day after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00493584, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2009.