Myocardial InfarctionOBTAINNCT00430612
The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)
An observational study of Myocardial Infarction, run by Northwestern University at 23 sites in 2 countries.
Trial summary
The purpose of the PACE-MI (OBTAIN) registry is: Analyze beta-blocker dose response effect on outcome over two years Explore gender and minority differences in beta-blocker utilization and outcomes. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Myocardial Infarction
- How many people
- 7,057 participants
- Where
- 23 sitesin 2 countries
- Study dates
- May 2009to Oct 2015
- How long will I take part?
- 2 Years
- Phase
- Observational
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: non-voluntary registry of consecutive patients diagnosed as having a MI at each study site
Who may be able to join
- 1. Consecutive patients admitted with a myocardial infarction documented by both of the following:
- cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab)
- Electrocardiographic changes and/or symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath)
- No Exclusion Criteria
Who cannot join
None listed.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Amarillo Heart Clinic Research Institute, Inc.
Amarillo, Texas, 79106
Austin Heart PLLC
Austin, Texas, 78756
Winthrop University Hospital
Bethpage, New York, 11714
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Maimonides Medical Center
Brooklyn, New York, 11219
Fletcher Allen Health Care
Burlington, Vermont, 05401
Northwestern Memorial Hospital
Chicago, Illinois, 60611
OhioHealth Research Institute
Columbus, Ohio, 43214
Henry Ford Hospital
Detroit, Michigan, 48202
Clarian Health/Methodist Research Institute
Indianapolis, Indiana, 46202
Little Rock Cardiology Clinic
Little Rock, Arkansas, 72211
MemorialCare Heart and Vascular Institute - Long Beach Memorial Medical Center
Long Beach, California, 90806
West Los Angeles VA Medical Center
Los Angeles, California, 90073
Baptist Memorial Hospital
Memphis, Tennessee, 38120
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Orlando Regional Medical Center
Orlando, Florida, 32806
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
Strong Memorial Hospital (University of Rochester School of Medicine)
Rochester, New York, 14642
Park Nicollet
Saint Louis Park, Minnesota, 55426
Providence Health Center
Waco, Texas, 76712
About this study
The purpose of the PACE-MI (OBTAIN) registry is:
- Analyze beta-blocker dose response effect on outcome over two years
- Explore gender and minority differences in beta-blocker utilization and outcomes.
In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose will be predictive of survival.
Exploratory analyses: Gender and racial effects-gender and race are, similarly, hypothesized to be predictive of post-MI survival.
The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated.
Read the detailed description
Methods
All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry. At the time of discharge from the coronary care unit, clinical data will be entered. The registry will include approximately 6800 patients.
As there is no intervention in the registry, the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization, there will be no consent specifically for registry patients at baseline. Systems have been implemented to ensure the registry data will remain confidential. Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data.
Data to be collected will include demographic (including ethnic and race classifications according to NIH guidelines) data and information regarding the index myocardial infarction. Use of beta-blockers at discharge from the coronary care unit will be documented. In addition, beta-blocker use at hospital discharge will be noted. Data for the registry will be obtained from ER notes, admission notes, cardiac catheterization lab reports, medication lists, lab reports, and discharge summaries.
Follow-Up
Follow-up for registry patients will be conducted at year 1 and year 2 post-myocardial infarction. Data may be obtained via medical chart review, phone contact, and Social Security Death Index (SSDI). For follow-up information obtained via chart review or the SSDI, a detailed justification for waiver of HIPAA and consent requirements is attached to this protocol. If phone contact is required with the patient, we are suggesting the following process:
- A letter should be sent out to the patient approximately one week prior to the contact in which the rationale for the study will be provided, as well as a delineation of the patient's right to participate or not to participate (by either providing or not providing the requested information).
- At telephone contact with the patient, the coordinator will document whether the patient consents to provide the information. If the patient consents, the coordinator will proceed to obtain the requested information.
- In the event that the participating institution's IRB requires a written, signed consent for this verbal contact, a written consent form template is provided.
Data collected at follow-up interview will include vital status, beta-blocker use, other cardiac medications and any cardiovascular hospitalizations.
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Heart Attack, Beta Blockers, Survival
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Registry Participants | Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total mortality at 2 years post myocardial infarction
Compare Kaplan Meier survival curves for the following 5 beta-blocker dose groups:
No beta-blockers - 12.5% (>0 - 12.5%) 25% (>12.5 - 25%) - 50% (>25 - 50%) Full Dose (>50%)
Measured: Measured at Years 1 and 2
Secondary outcomes (1)
Total mortality - secondary analysis
Compare Kaplan-Meier survival curves for the following 2 beta-blocker dose groups:
Very Low Dose (>0-25%) vs. High Dose (≥50%)
Measured: Measured at Year 1 and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startMay 2009
- Primary completionDec 2013
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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 Northwestern UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 7,057 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jeff Goldberger, Northwestern University
- Investigators
- Jeffrey Goldberger, MD, MBA, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430612
- Sponsor's protocol ID
- 469
- Other IDs
- U01HL080416
- Acronym
- OBTAIN
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2007
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wikstrand J, Hjalmarson A, Waagstein F, Fagerberg B, Goldstein S, Kjekshus J, Wedel H; MERIT-HF Study Group. Dose of metoprolol CR/XL and clinical outcomes in patients with heart failure: analysis of the experience in metoprolol CR/XL randomized intervention trial in chronic heart failure (MERIT-HF). J Am Coll Cardiol. 2002 Aug 7;40(3):491-8. doi: 10.1016/s0735-1097(02)01970-8.
PubMed 12142116Metra M, Torp-Pedersen C, Swedberg K, Cleland JG, Di Lenarda A, Komajda M, Remme WJ, Lutiger B, Scherhag A, Lukas MA, Charlesworth A, Poole-Wilson PA. Influence of heart rate, blood pressure, and beta-blocker dose on outcome and the differences in outcome between carvedilol and metoprolol tartrate in patients with chronic heart failure: results from the COMET trial. Eur Heart J. 2005 Nov;26(21):2259-68. doi: 10.1093/eurheartj/ehi386. Epub 2005 Jul 21.
PubMed 16040619Dobre D, van Veldhuisen DJ, Mordenti G, Vintila M, Haaijer-Ruskamp FM, Coats AJ, Poole-Wilson PA, Flather MD; SENIORS Investigators. Tolerability and dose-related effects of nebivolol in elderly patients with heart failure: data from the Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure (SENIORS) trial. Am Heart J. 2007 Jul;154(1):109-15. doi: 10.1016/j.ahj.2007.03.025.
PubMed 17584562Cucherat M. Quantitative relationship between resting heart rate reduction and magnitude of clinical benefits in post-myocardial infarction: a meta-regression of randomized clinical trials. Eur Heart J. 2007 Dec;28(24):3012-9. doi: 10.1093/eurheartj/ehm489. Epub 2007 Nov 2.
PubMed 17981830Kjekshus JK. Importance of heart rate in determining beta-blocker efficacy in acute and long-term acute myocardial infarction intervention trials. Am J Cardiol. 1986 Apr 25;57(12):43F-49F. doi: 10.1016/0002-9149(86)90888-x.
PubMed 2871745Chen ZM, Pan HC, Chen YP, Peto R, Collins R, Jiang LX, Xie JX, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1622-32. doi: 10.1016/S0140-6736(05)67661-1.
PubMed 16271643POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.
PubMed 18479744Gottlieb S, Harpaz D, Shotan A, Boyko V, Leor J, Cohen M, Mandelzweig L, Mazouz B, Stern S, Behar S. Sex differences in management and outcome after acute myocardial infarction in the 1990s: A prospective observational community-based study. Israeli Thrombolytic Survey Group. Circulation. 2000 Nov 14;102(20):2484-90. doi: 10.1161/01.cir.102.20.2484.
PubMed 11076821Wilkinson P, Laji K, Ranjadayalan K, Parsons L, Timmis AD. Acute myocardial infarction in women: survival analysis in first six months. BMJ. 1994 Sep 3;309(6954):566-9. doi: 10.1136/bmj.309.6954.566.
PubMed 7916229Mahon NG, McKenna CJ, Codd MB, O'Rorke C, McCann HA, Sugrue DD. Gender differences in the management and outcome of acute myocardial infarction in unselected patients in the thrombolytic era. Am J Cardiol. 2000 Apr 15;85(8):921-6. doi: 10.1016/s0002-9149(99)00902-9.
PubMed 10760327Vaccarino V, Krumholz HM, Yarzebski J, Gore JM, Goldberg RJ. Sex differences in 2-year mortality after hospital discharge for myocardial infarction. Ann Intern Med. 2001 Feb 6;134(3):173-81. doi: 10.7326/0003-4819-134-3-200102060-00007.
PubMed 11177329A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982 Mar 26;247(12):1707-14. doi: 10.1001/jama.1982.03320370021023.
PubMed 7038157Olsson G, Wikstrand J, Warnold I, Manger Cats V, McBoyle D, Herlitz J, Hjalmarson A, Sonneblick EH. Metoprolol-induced reduction in postinfarction mortality: pooled results from five double-blind randomized trials. Eur Heart J. 1992 Jan;13(1):28-32. doi: 10.1093/oxfordjournals.eurheartj.a060043.
PubMed 1533587Rochon PA, Anderson GM, Tu JV, Clark JP, Gurwitz JH, Szalai JP, Lau P. Use of beta-blocker therapy in older patients after acute myocardial infarction in Ontario. CMAJ. 1999 Nov 30;161(11):1403-8.
PubMed 10906894Soumerai SB, McLaughlin TJ, Spiegelman D, Hertzmark E, Thibault G, Goldman L. Adverse outcomes of underuse of beta-blockers in elderly survivors of acute myocardial infarction. JAMA. 1997 Jan 8;277(2):115-21.
PubMed 8990335
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PACE-MI Registry Study - Outcomes of Beta-blocker Therapy After Myocardial Infarction (OBTAIN)
- ClinicalTrials.gov ID
- NCT00430612
- Acronym / sponsor ID
- OBTAIN / 469
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Heart Attack, Beta Blockers, Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,057 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- May 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Feb 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 the PACE-MI (OBTAIN) registry is:
- Analyze beta-blocker dose response effect on outcome over two years
- Explore gender and minority differences in beta-blocker utilization and outcomes.
In patients with Myocardial Infarction (MI) discharged from the hospital, beta-blocker dose will be predictive of survival.
Exploratory analyses: Gender and racial effects-gender and race are, similarly, hypothesized to be predictive of post-MI survival.
The existence of interactions between gender and beta-blocker effect as well as race and beta-blocker effect will also be evaluated.
Detailed description
Methods
All patients admitted to the coronary care areas with an acute myocardial infarction will be entered into the registry. At the time of discharge from the coronary care unit, clinical data will be entered. The registry will include approximately 6800 patients.
As there is no intervention in the registry, the data to be collected are standard for quality assurance purposes and cannot practicably be carried out without waivers of consent and HIPAA authorization, there will be no consent specifically for registry patients at baseline. Systems have been implemented to ensure the registry data will remain confidential. Sites have received IRB approval of waiver of consent and HIPAA for the baseline registry data.
Data to be collected will include demographic (including ethnic and race classifications according to NIH guidelines) data and information regarding the index myocardial infarction. Use of beta-blockers at discharge from the coronary care unit will be documented. In addition, beta-blocker use at hospital discharge will be noted. Data for the registry will be obtained from ER notes, admission notes, cardiac catheterization lab reports, medication lists, lab reports, and discharge summaries.
Follow-Up
Follow-up for registry patients will be conducted at year 1 and year 2 post-myocardial infarction. Data may be obtained via medical chart review, phone contact, and Social Security Death Index (SSDI). For follow-up information obtained via chart review or the SSDI, a detailed justification for waiver of HIPAA and consent requirements is attached to this protocol. If phone contact is required with the patient, we are suggesting the following process:
- A letter should be sent out to the patient approximately one week prior to the contact in which the rationale for the study will be provided, as well as a delineation of the patient's right to participate or not to participate (by either providing or not providing the requested information).
- At telephone contact with the patient, the coordinator will document whether the patient consents to provide the information. If the patient consents, the coordinator will proceed to obtain the requested information.
- In the event that the participating institution's IRB requires a written, signed consent for this verbal contact, a written consent form template is provided.
Data collected at follow-up interview will include vital status, beta-blocker use, other cardiac medications and any cardiovascular hospitalizations.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Registry Participants | – | –Non-voluntary registry of consecutive patients diagnosed as having a MI at each study site. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- non-voluntary registry of consecutive patients diagnosed as having a MI at each study site
Key inclusion criteria (4 listed)
- 1. Consecutive patients admitted with a myocardial infarction documented by both of the following:
- cardiac enzymes (CPK elevation > two times or troponin elevation > three times the upper limit of normal for the lab)
- Electrocardiographic changes and/or symptoms consistent with myocardial infarction (i.e. chest pain, shortness of breath)
- No Exclusion Criteria
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total mortality at 2 years post myocardial infarction
Time frame: Measured at Years 1 and 2
Compare Kaplan Meier survival curves for the following 5 beta-blocker dose groups: No beta-blockers - 12.5% (>0 - 12.5%) 25% (>12.5 - 25%) - 50% (>25 - 50%) Full Dose (>50%)
1 secondary outcome
Total mortality - secondary analysis
Time frame: Measured at Year 1 and Year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Background: PubMed 12142116Wikstrand J, Hjalmarson A, Waagstein F, Fagerberg B, Goldstein S, Kjekshus J, Wedel H; MERIT-HF Study Group. Dose of metoprolol CR/XL and clinical outcomes in patients with heart failure: analysis of the experience in metoprolol CR/XL randomized intervention trial in chronic heart failure (MERIT-HF). J Am Coll Cardiol. 2002 Aug 7;40(3):491-8. doi: 10.1016/s0735-1097(02)01970-8.
- Background: PubMed 16040619Metra M, Torp-Pedersen C, Swedberg K, Cleland JG, Di Lenarda A, Komajda M, Remme WJ, Lutiger B, Scherhag A, Lukas MA, Charlesworth A, Poole-Wilson PA. Influence of heart rate, blood pressure, and beta-blocker dose on outcome and the differences in outcome between carvedilol and metoprolol tartrate in patients with chronic heart failure: results from the COMET trial. Eur Heart J. 2005 Nov;26(21):2259-68. doi: 10.1093/eurheartj/ehi386. Epub 2005 Jul 21.
- Background: PubMed 17584562Dobre D, van Veldhuisen DJ, Mordenti G, Vintila M, Haaijer-Ruskamp FM, Coats AJ, Poole-Wilson PA, Flather MD; SENIORS Investigators. Tolerability and dose-related effects of nebivolol in elderly patients with heart failure: data from the Study of the Effects of Nebivolol Intervention on Outcomes and Rehospitalisation in Seniors with Heart Failure (SENIORS) trial. Am Heart J. 2007 Jul;154(1):109-15. doi: 10.1016/j.ahj.2007.03.025.
- Background: PubMed 17981830Cucherat M. Quantitative relationship between resting heart rate reduction and magnitude of clinical benefits in post-myocardial infarction: a meta-regression of randomized clinical trials. Eur Heart J. 2007 Dec;28(24):3012-9. doi: 10.1093/eurheartj/ehm489. Epub 2007 Nov 2.
- Background: PubMed 2871745Kjekshus JK. Importance of heart rate in determining beta-blocker efficacy in acute and long-term acute myocardial infarction intervention trials. Am J Cardiol. 1986 Apr 25;57(12):43F-49F. doi: 10.1016/0002-9149(86)90888-x.
- Background: PubMed 16271643Chen ZM, Pan HC, Chen YP, Peto R, Collins R, Jiang LX, Xie JX, Liu LS; COMMIT (ClOpidogrel and Metoprolol in Myocardial Infarction Trial) collaborative group. Early intravenous then oral metoprolol in 45,852 patients with acute myocardial infarction: randomised placebo-controlled trial. Lancet. 2005 Nov 5;366(9497):1622-32. doi: 10.1016/S0140-6736(05)67661-1.
- Background: PubMed 18479744POISE Study Group; Devereaux PJ, Yang H, Yusuf S, Guyatt G, Leslie K, Villar JC, Xavier D, Chrolavicius S, Greenspan L, Pogue J, Pais P, Liu L, Xu S, Malaga G, Avezum A, Chan M, Montori VM, Jacka M, Choi P. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet. 2008 May 31;371(9627):1839-47. doi: 10.1016/S0140-6736(08)60601-7. Epub 2008 May 12.
- Background: PubMed 11076821Gottlieb S, Harpaz D, Shotan A, Boyko V, Leor J, Cohen M, Mandelzweig L, Mazouz B, Stern S, Behar S. Sex differences in management and outcome after acute myocardial infarction in the 1990s: A prospective observational community-based study. Israeli Thrombolytic Survey Group. Circulation. 2000 Nov 14;102(20):2484-90. doi: 10.1161/01.cir.102.20.2484.
- Background: PubMed 7916229Wilkinson P, Laji K, Ranjadayalan K, Parsons L, Timmis AD. Acute myocardial infarction in women: survival analysis in first six months. BMJ. 1994 Sep 3;309(6954):566-9. doi: 10.1136/bmj.309.6954.566.
- Background: PubMed 10760327Mahon NG, McKenna CJ, Codd MB, O'Rorke C, McCann HA, Sugrue DD. Gender differences in the management and outcome of acute myocardial infarction in unselected patients in the thrombolytic era. Am J Cardiol. 2000 Apr 15;85(8):921-6. doi: 10.1016/s0002-9149(99)00902-9.
- Background: PubMed 11177329Vaccarino V, Krumholz HM, Yarzebski J, Gore JM, Goldberg RJ. Sex differences in 2-year mortality after hospital discharge for myocardial infarction. Ann Intern Med. 2001 Feb 6;134(3):173-81. doi: 10.7326/0003-4819-134-3-200102060-00007.
- Background: PubMed 7038157A randomized trial of propranolol in patients with acute myocardial infarction. I. Mortality results. JAMA. 1982 Mar 26;247(12):1707-14. doi: 10.1001/jama.1982.03320370021023.
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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.
Jeffrey Goldberger, MD, MBA principal investigator
Northwestern University
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Northwestern University at 23 sites in 2 countries.
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 4 inclusion and 0 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: finished, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total mortality at 2 years post myocardial infarction (time frame: Measured at Years 1 and 2). 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 NCT00430612, which also lists 28 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 24 Apr 2023.