Myocardial InfarctionNCT00149591
The Viability-Guided Angioplasty After Acute Myocardial Infarction-Trial (The VIAMI-Trial)
A study testing coronary balloon-angioplasty with stenting in people with Myocardial Infarction and Coronary Artery Disease, run by Netherlands Heart Foundation at 12 sites in Netherlands.
Trial summary
The VIAMI-trial investigates the effects of balloon angioplasty with stenting of the infarct-vessel in the early phase after acute myocardial infarction. The study concerns patients who have residual viable tissue in the infarct-area after being treated with thrombolysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- coronary balloon-angioplasty with stenting
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 12 sitesNetherlands
- Study dates
- Apr 2001to Jan 2007
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission within 6 hours of pain onset and EKG with ≥ 1 mm ST-segment elevation in two or more standard leads or ≥ 2 mm ST-elevation in two contiguous chest leads, indicative for transmural ischemia, with or without the development of new Q-waves, with myocardial necrosis proven by enzyme rise (total CPK ≥ 2x the upper normal limit).
- Patient history compatible with subacute myocardial infarction ( ≥ 6 hours), with at least signs of myocardial necrosis on the EKG (Q-waves) and a significantly increased serum level of cardiac-specific enzymes.
- Age between 18 and 80 years.
- Viability testing performed prior to coronary angiography.
- No clinical indication for an invasive procedure to be performed before viability testing
Who cannot join
- No informed consent obtained
- Unreliable follow-up
- Viability testing technically not possible
- Contra-indications for dobutamine echocardiography (heart failure, arrhythmia)
- Contra-indications for coronary angiography, such as severe diabetic nephropathy or know contrast-allergy
- Known hypersensitivity for abciximab
- Serious, life-threatening non-cardiac illness
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Netherlands12 sites
Medical Center Alkmaar (MCA)
Alkmaar, 1815 JD
Sint LucasAndreas Hospital
Amsterdam, 1058 NR
VU University medical center
Amsterdam, 1081 HV
Catharina Hospital
Eindhoven, 5623 EJ
Kennemer Gasthuis
Haarlem, 2000 AK
Atrium Medical Center Heerlen
Heerlen, 6401 CX
Hospital Hilversum
Hilversum, 1213 XZ
Rijnland Hospital
Leiderdorp, 2350 CC
University Medical Center St. Radboud
Nijmegen, 6525 GA
Waterland Hospital
Purmerend, 1441 RN
Diakonessenhuis
Utrecht, 3582 KE
Zaans Medical Center "De Heel"
Zaandam, 1500 EE
About this study
Official title: Early and Long-Term Outcome of Elective Stenting of the Infarct-Related Artery in Patients With Viability in the Infarct-Area Early After Acute Myocardial Infarction. The VIAMI-Trial.
The VIAMI-trial investigates the effects of balloon angioplasty with stenting of the infarct-vessel in the early phase after acute myocardial infarction. The study concerns patients who have residual viable tissue in the infarct-area after being treated with thrombolysis. It is postulated that only patients with remaining viable tissue are at high-risk for recurrent infarction or anginal attacks and that stenting of the infarct-vessel will reduce this risk considerably.
Read the detailed description
Earlier studies have shown that routine angioplasty of the infarct-related coronary artery soon after thrombolysis for acute myocardial infarction did not result in a clinical benefit. This finding emphasizes the importance to select a subgroup of patients with a recent myocardial infarction, who will really benefit from angioplasty of the infarct-related artery.
Several studies have demonstrated that the presence of viability in the infarct-area early after acute myocardial infarction imposes an increased risk of new cardiac events like recurrent infarction, angina pectoris and need for coronary interventions. Therefore, it is postulated that only patients with viability in the infarct-area will benefit from angioplasty early after acute myocardial infarction.
In the VIAMI-trial patients who are admitted to the hospital with an acute myocardial infarction and who did not undergo immediate coronary angioplasty, will undergo viability testing by dobutamine-echocardiography within 3 days of admission. Patients with unequivocal signs of viability in the infarct-area will then be randomized to an invasive or a conservative treatment strategy. In the invasive strategy patients will undergo coronary angiography with the intention to perform balloon angioplasty with stenting of the infarct-related coronary artery, with concomitant use of the intravenous platelet inhibitor abciximab. In the conservative group patients will undergo coronary angiography and angioplasty only when new impending infarction or recurrent ischemia is present. In the invasive group balloon angioplasty will be performed as soon as possible after randomization. Patients without viability will not be randomized,but will participate as a control group.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- coronary balloon-angioplasty with stenting
- Keywords
- Myocardial infarction, Viability, Coronary angioplasty, Prevention, Prognosis
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary balloon-angioplasty with stentingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Recurrent myocardial infarction
Unstable angina for which hospital admission required
Analysis at 30 days, 6 months and 1 year
Secondary outcomes (5)
Left ventricular function (Echocardiography)
Incidence of heart failure (NYHA)
Angina pectoris class (CCS)
Need for revascularization procedures
Analysis at 3 and 6 months and after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2001
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Netherlands Heart Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- The Interuniversity Cardiology Institute of the Netherlands, Eli Lilly and Company, Boehringer Ingelheim, Bristol-Myers Squibb
- Investigators
- Gerrit Veen, MD, PhD, Principal investigator, VU University medical center, Amsterdam, The NetherlandsCees A Visser, MD, PhD, Study chair, VU University medical center, Amsterdam, The NetherlandsFrans C Visser, MD, PhD, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149591
- Sponsor's protocol ID
- 2000B026
- Other IDs
- H4S-UT-O017
- Status last verified
- Sep 2006
- First submitted
- 6 Sep 2005
- Last updated
- 5 Sep 2008
- Results posted
- No
Publications
Gunnar RM, Passamani ER, Bourdillon PD, Pitt B, Dixon DW, Rapaport E, Fuster V, Reeves TJ, Karp RB, Russell RO Jr, et al. Guidelines for the early management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee to Develop Guidelines for the Early Management of Patients with Acute Myocardial Infarction). J Am Coll Cardiol. 1990 Aug;16(2):249-92. doi: 10.1016/0735-1097(90)90575-a. No abstract available.
PubMed 2197309Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Ornato JP. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004 Aug 4;44(3):E1-E211. doi: 10.1016/j.jacc.2004.07.014. No abstract available.
PubMed 15358047Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
PubMed 12517460Van de Werf F, Ardissino D, Betriu A, Cokkinos DV, Falk E, Fox KA, Julian D, Lengyel M, Neumann FJ, Ruzyllo W, Thygesen C, Underwood SR, Vahanian A, Verheugt FW, Wijns W; Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2003 Jan;24(1):28-66. doi: 10.1016/s0195-668x(02)00618-8. No abstract available.
PubMed 12559937Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. doi: 10.1053/euhj.2002.3193.
PubMed 12127921Morrow DA, Antman EM, Parsons L, de Lemos JA, Cannon CP, Giugliano RP, McCabe CH, Barron HV, Braunwald E. Application of the TIMI risk score for ST-elevation MI in the National Registry of Myocardial Infarction 3. JAMA. 2001 Sep 19;286(11):1356-9. doi: 10.1001/jama.286.11.1356.
PubMed 11560541GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. Lancet. 1990 Jul 14;336(8707):65-71.
PubMed 1975321ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. Lancet. 1992 Mar 28;339(8796):753-70.
PubMed 1347801GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med. 1993 Nov 25;329(22):1615-22. doi: 10.1056/NEJM199311253292204.
PubMed 8232430Meijer A, Verheugt FW, Werter CJ, Lie KI, van der Pol JM, van Eenige MJ. Aspirin versus coumadin in the prevention of reocclusion and recurrent ischemia after successful thrombolysis: a prospective placebo-controlled angiographic study. Results of the APRICOT Study. Circulation. 1993 May;87(5):1524-30. doi: 10.1161/01.cir.87.5.1524.
PubMed 8491007Veen G, Meyer A, Verheugt FW, Werter CJ, de Swart H, Lie KI, van der Pol JM, Michels HR, van Eenige MJ. Culprit lesion morphology and stenosis severity in the prediction of reocclusion after coronary thrombolysis: angiographic results of the APRICOT study. Antithrombotics in the Prevention of Reocclusion in Coronary Thrombolysis. J Am Coll Cardiol. 1993 Dec;22(7):1755-62. doi: 10.1016/0735-1097(93)90754-o.
PubMed 8245325Meijer A, Verheugt FW, van Eenige MJ, Werter CJ. Left ventricular function at 3 months after successful thrombolysis. Impact of reocclusion without reinfarction on ejection fraction, regional function, and remodeling. Circulation. 1994 Oct;90(4):1706-14. doi: 10.1161/01.cir.90.4.1706.
PubMed 7923654Nijland F, Kamp O, Verheugt FW, Veen G, Visser CA. Long-term implications of reocclusion on left ventricular size and function after successful thrombolysis for first anterior myocardial infarction. Circulation. 1997 Jan 7;95(1):111-7. doi: 10.1161/01.cir.95.1.111.
PubMed 8994425TIMI Study Group. Comparison of invasive and conservative strategies after treatment with intravenous tissue plasminogen activator in acute myocardial infarction. Results of the thrombolysis in myocardial infarction (TIMI) phase II trial. N Engl J Med. 1989 Mar 9;320(10):618-27. doi: 10.1056/NEJM198903093201002.
PubMed 2563896SWIFT trial of delayed elective intervention v conservative treatment after thrombolysis with anistreplase in acute myocardial infarction. SWIFT (Should We Intervene Following Thrombolysis?) Trial Study Group. BMJ. 1991 Mar 9;302(6776):555-60. doi: 10.1136/bmj.302.6776.555.
PubMed 2021717
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Long-Term Outcome of Elective Stenting of the Infarct-Related Artery in Patients With Viability in the Infarct-Area Early After Acute Myocardial Infarction. The VIAMI-Trial.
- ClinicalTrials.gov ID
- NCT00149591
- Acronym / sponsor ID
- 2000B026
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- Myocardial infarction, Viability, Coronary angioplasty, Prevention, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants
- Lead sponsor
- Netherlands Heart FoundationUniversity, hospital or other
- Collaborators
- The Interuniversity Cardiology Institute of the Netherlands, Eli Lilly and Company, Boehringer Ingelheim, Bristol-Myers Squibb
- Study start
- Apr 2001
- Study completion
- Jan 2007
- First posted
- 8 Sep 2005 (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 VIAMI-trial investigates the effects of balloon angioplasty with stenting of the infarct-vessel in the early phase after acute myocardial infarction. The study concerns patients who have residual viable tissue in the infarct-area after being treated with thrombolysis. It is postulated that only patients with remaining viable tissue are at high-risk for recurrent infarction or anginal attacks and that stenting of the infarct-vessel will reduce this risk considerably.
Detailed description
Earlier studies have shown that routine angioplasty of the infarct-related coronary artery soon after thrombolysis for acute myocardial infarction did not result in a clinical benefit. This finding emphasizes the importance to select a subgroup of patients with a recent myocardial infarction, who will really benefit from angioplasty of the infarct-related artery.
Several studies have demonstrated that the presence of viability in the infarct-area early after acute myocardial infarction imposes an increased risk of new cardiac events like recurrent infarction, angina pectoris and need for coronary interventions. Therefore, it is postulated that only patients with viability in the infarct-area will benefit from angioplasty early after acute myocardial infarction.
In the VIAMI-trial patients who are admitted to the hospital with an acute myocardial infarction and who did not undergo immediate coronary angioplasty, will undergo viability testing by dobutamine-echocardiography within 3 days of admission. Patients with unequivocal signs of viability in the infarct-area will then be randomized to an invasive or a conservative treatment strategy. In the invasive strategy patients will undergo coronary angiography with the intention to perform balloon angioplasty with stenting of the infarct-related coronary artery, with concomitant use of the intravenous platelet inhibitor abciximab. In the conservative group patients will undergo coronary angiography and angioplasty only when new impending infarction or recurrent ischemia is present. In the invasive group balloon angioplasty will be performed as soon as possible after randomization. Patients without viability will not be randomized,but will participate as a control group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Admission within 6 hours of pain onset and EKG with ≥ 1 mm ST-segment elevation in two or more standard leads or ≥ 2 mm ST-elevation in two contiguous chest leads, indicative for transmural ischemia, with or without the development of new Q-waves, with myocardial necrosis proven by enzyme rise (total CPK ≥ 2x the upper normal limit).
- Patient history compatible with subacute myocardial infarction ( ≥ 6 hours), with at least signs of myocardial necrosis on the EKG (Q-waves) and a significantly increased serum level of cardiac-specific enzymes.
- Age between 18 and 80 years.
- Viability testing performed prior to coronary angiography.
- No clinical indication for an invasive procedure to be performed before viability testing
Key exclusion criteria (7 listed)
- No informed consent obtained
- Unreliable follow-up
- Viability testing technically not possible
- Contra-indications for dobutamine echocardiography (heart failure, arrhythmia)
- Contra-indications for coronary angiography, such as severe diabetic nephropathy or know contrast-allergy
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 |
|---|---|---|
| coronary balloon-angioplasty with stenting | Procedure or surgery | – |
Primary outcome
Death
Recurrent myocardial infarction
Unstable angina for which hospital admission required
Analysis at 30 days, 6 months and 1 year
5 secondary outcomes
Left ventricular function (Echocardiography)
Incidence of heart failure (NYHA)
Angina pectoris class (CCS)
Need for revascularization procedures
Analysis at 3 and 6 months and after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2008.
- Background: PubMed 2197309Gunnar RM, Passamani ER, Bourdillon PD, Pitt B, Dixon DW, Rapaport E, Fuster V, Reeves TJ, Karp RB, Russell RO Jr, et al. Guidelines for the early management of patients with acute myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee to Develop Guidelines for the Early Management of Patients with Acute Myocardial Infarction). J Am Coll Cardiol. 1990 Aug;16(2):249-92. doi: 10.1016/0735-1097(90)90575-a. No abstract available.
- Background: PubMed 15358047Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK, Ornato JP. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction; A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of patients with acute myocardial infarction). J Am Coll Cardiol. 2004 Aug 4;44(3):E1-E211. doi: 10.1016/j.jacc.2004.07.014. No abstract available.
- Background: PubMed 12517460Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.
- Background: PubMed 12559937Van de Werf F, Ardissino D, Betriu A, Cokkinos DV, Falk E, Fox KA, Julian D, Lengyel M, Neumann FJ, Ruzyllo W, Thygesen C, Underwood SR, Vahanian A, Verheugt FW, Wijns W; Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Management of acute myocardial infarction in patients presenting with ST-segment elevation. The Task Force on the Management of Acute Myocardial Infarction of the European Society of Cardiology. Eur Heart J. 2003 Jan;24(1):28-66. doi: 10.1016/s0195-668x(02)00618-8. No abstract available.
- Background: PubMed 12127921Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. doi: 10.1053/euhj.2002.3193.
- Background: PubMed 11560541Morrow DA, Antman EM, Parsons L, de Lemos JA, Cannon CP, Giugliano RP, McCabe CH, Barron HV, Braunwald E. Application of the TIMI risk score for ST-elevation MI in the National Registry of Myocardial Infarction 3. JAMA. 2001 Sep 19;286(11):1356-9. doi: 10.1001/jama.286.11.1356.
- Background: PubMed 1975321GISSI-2: a factorial randomised trial of alteplase versus streptokinase and heparin versus no heparin among 12,490 patients with acute myocardial infarction. Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico. Lancet. 1990 Jul 14;336(8707):65-71.
- Background: PubMed 1347801ISIS-3: a randomised comparison of streptokinase vs tissue plasminogen activator vs anistreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. ISIS-3 (Third International Study of Infarct Survival) Collaborative Group. Lancet. 1992 Mar 28;339(8796):753-70.
- Background: PubMed 8232430GUSTO Angiographic Investigators. The effects of tissue plasminogen activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med. 1993 Nov 25;329(22):1615-22. doi: 10.1056/NEJM199311253292204.
- Background: PubMed 8491007Meijer A, Verheugt FW, Werter CJ, Lie KI, van der Pol JM, van Eenige MJ. Aspirin versus coumadin in the prevention of reocclusion and recurrent ischemia after successful thrombolysis: a prospective placebo-controlled angiographic study. Results of the APRICOT Study. Circulation. 1993 May;87(5):1524-30. doi: 10.1161/01.cir.87.5.1524.
- Background: PubMed 8245325Veen G, Meyer A, Verheugt FW, Werter CJ, de Swart H, Lie KI, van der Pol JM, Michels HR, van Eenige MJ. Culprit lesion morphology and stenosis severity in the prediction of reocclusion after coronary thrombolysis: angiographic results of the APRICOT study. Antithrombotics in the Prevention of Reocclusion in Coronary Thrombolysis. J Am Coll Cardiol. 1993 Dec;22(7):1755-62. doi: 10.1016/0735-1097(93)90754-o.
- Background: PubMed 7923654Meijer A, Verheugt FW, van Eenige MJ, Werter CJ. Left ventricular function at 3 months after successful thrombolysis. Impact of reocclusion without reinfarction on ejection fraction, regional function, and remodeling. Circulation. 1994 Oct;90(4):1706-14. doi: 10.1161/01.cir.90.4.1706.
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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.
Gerrit Veen, MD, PhD principal investigator
VU University medical center, Amsterdam, The Netherlands
Cees A Visser, MD, PhD study chair
VU University medical center, Amsterdam, The Netherlands
Frans C Visser, MD, PhD study director
Amsterdam UMC, location VUmc
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronary balloon-angioplasty with stenting in people with Myocardial Infarction and Coronary Artery Disease, run by Netherlands Heart Foundation at 12 sites in Netherlands.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 5 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands. 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?
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?
Death. The study lists 4 primary outcomes in all. 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 NCT00149591, which also lists 48 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 5 Sep 2008.