Myocardial InfarctionEDAMINCT01868256
Safety of Early Discharge Following Low Risk Myocardial Infarction
A study testing early discharge (<72 h) and Conventional discharge in people with Myocardial Infarction, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- early discharge (<72 h) and Conventional discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,558 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to Feb 2014
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset
- Informed consent
Who cannot join
- arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)
- mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)
- severe or moderate bleeding (according to the GUSTO criteria)
- complications related to vascular access of the procedure
- acute kidney failure
- infection
- heart failure
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Alessandro Sionis, MD, + 34 935565945, asionis@santpau.cat
Alessandro Sionis, MD
About this study
Official title: Safety of a Early Discharge Strategy in Patients With Low-risk ST-segment Elevation Myocardial Infarction Treated With Primary Coronary Intervention: a Randomized Controlled Trial
- Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.
- Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days.
- Conditions
- Myocardial Infarction
- Being tested
- early discharge (<72 h), Conventional discharge
- Keywords
- myocardial infarction, primary percutaneous intervention, prognosis, early discharge
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early discharge (<72 h)Other
Conventional dischargeOther
| Study group | Role | What they receive |
|---|---|---|
| Early discharge (< 72 h) | Experimental | Patients randomized the early discharge group will be discharged from the hospital in < 72 hours Receives: Other: early discharge (<72 h) |
| Conventional discharge | Active comparator | Patients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion Receives: Other: Conventional discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.
Composite primary end-point
Measured: 1 month
Secondary outcomes (7)
All cause mortality
Measured: 1 month
Myocardial infarction
Measured: 1 month
Unstable angina
Measured: 1 month
Heart failure
Measured: 1 month
Ventricular arrhythmias
Measured: 1 month
Stroke
Measured: 1 month
Severe bleeding
According to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) classification
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study startJan 2012
- Primary completionJan 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,558 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Sionis, MD, Principal investigator, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868256
- Sponsor's protocol ID
- IIBSP-PAP-2011-07
- Acronym
- EDAMI
- Status last verified
- May 2013
- First submitted
- 23 Nov 2012
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Newby LK, Eisenstein EL, Califf RM, Thompson TD, Nelson CL, Peterson ED, Armstrong PW, Van de Werf F, White HD, Topol EJ, Mark DB. Cost effectiveness of early discharge after uncomplicated acute myocardial infarction. N Engl J Med. 2000 Mar 16;342(11):749-55. doi: 10.1056/NEJM200003163421101.
PubMed 10717009De Luca G, Suryapranata H, van 't Hof AW, de Boer MJ, Hoorntje JC, Dambrink JH, Gosselink AT, Ottervanger JP, Zijlstra F. Prognostic assessment of patients with acute myocardial infarction treated with primary angioplasty: implications for early discharge. Circulation. 2004 Jun 8;109(22):2737-43. doi: 10.1161/01.CIR.0000131765.73959.87. Epub 2004 May 24.
PubMed 15159293Grines CL, Marsalese DL, Brodie B, Griffin J, Donohue B, Costantini CR, Balestrini C, Stone G, Wharton T, Esente P, Spain M, Moses J, Nobuyoshi M, Ayres M, Jones D, Mason D, Sachs D, Grines LL, O'Neill W. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998 Apr;31(5):967-72. doi: 10.1016/s0735-1097(98)00031-x.
PubMed 9561995Kotowycz MA, Cosman TL, Tartaglia C, Afzal R, Syal RP, Natarajan MK. Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial). Am Heart J. 2010 Jan;159(1):117.e1-6. doi: 10.1016/j.ahj.2009.10.024.
PubMed 20102876
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of a Early Discharge Strategy in Patients With Low-risk ST-segment Elevation Myocardial Infarction Treated With Primary Coronary Intervention: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01868256
- Acronym / sponsor ID
- EDAMI / IIBSP-PAP-2011-07
- Conditions
- Myocardial Infarction
- Keywords
- myocardial infarction, primary percutaneous intervention, prognosis, early discharge
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,558 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 4 Jun 2013 (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.
- Objectives: The primary objective of this study is to evaluate the safety of an early discharge strategy in patients with low risk ST-elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI), compared to a conventional strategy.
- Methodology: Unicentric, randomized, controlled, non-inferiority and open label clinical trial. The investigators will compare an early discharge strategy (≤72 hours) with a conventional strategy (discharge according to treating physician's criterion). Inclusion criteria will be: low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset. Exclusion criteria will be: arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block), mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis), severe or moderate bleeding (according to the GUSTO criteria), complications related to vascular access of the procedure, acute kidney failure, infection, heart failure. Sample size will be 1558 subjects (n=779 per group). The investigators will study demographic, clinical, biochemical, echocardiographic and angiographic variables. The primary endpoint will be a composite of death, reinfarction, new angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. The secondary endpoint will include each of the items of the primary endpoint and quality of life and functional capacity questionnaire SF-36. Finally, the investigators will analyze the degree of compliance with the European Society of Cardiology guidelines on STEMI and the rate of hospitalization-related complications. Follow up will be at 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early discharge (< 72 h) | Experimental | Other: early discharge (<72 h)Patients randomized the early discharge group will be discharged from the hospital in < 72 hours |
| Conventional discharge | Active comparator | Other: Conventional dischargePatients randomized to the conventional discharge group will be discharged according to the local hospital protocol and/or treating physician criterion |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- low risk (Zwolle risk score ≤3) STEMI treated with PPCI within 24 hours from symptoms onset
- Informed consent
Key exclusion criteria (7 listed)
- arrhythmias (ventricular tachycardia or fibrillation, asystole, pulseless electrical activity, advanced atrio-ventricular block)
- mechanical complications (cardiac tamponade, free-wall or septal rupture, acute mitral regurgitation, pericarditis)
- severe or moderate bleeding (according to the GUSTO criteria)
- complications related to vascular access of the procedure
- acute kidney failure
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 |
|---|---|---|
| early discharge (<72 h) | Other | Early discharge (< 72 h) |
| Conventional discharge | Other | Conventional discharge |
Primary outcome
All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding.
Time frame: 1 month
Composite primary end-point
7 secondary outcomes
All cause mortality
Time frame: 1 month
Myocardial infarction
Time frame: 1 month
Unstable angina
Time frame: 1 month
Heart failure
Time frame: 1 month
Ventricular arrhythmias
Time frame: 1 month
Stroke
Time frame: 1 month
Severe bleeding
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
- Background: PubMed 10717009Newby LK, Eisenstein EL, Califf RM, Thompson TD, Nelson CL, Peterson ED, Armstrong PW, Van de Werf F, White HD, Topol EJ, Mark DB. Cost effectiveness of early discharge after uncomplicated acute myocardial infarction. N Engl J Med. 2000 Mar 16;342(11):749-55. doi: 10.1056/NEJM200003163421101.
- Background: PubMed 15159293De Luca G, Suryapranata H, van 't Hof AW, de Boer MJ, Hoorntje JC, Dambrink JH, Gosselink AT, Ottervanger JP, Zijlstra F. Prognostic assessment of patients with acute myocardial infarction treated with primary angioplasty: implications for early discharge. Circulation. 2004 Jun 8;109(22):2737-43. doi: 10.1161/01.CIR.0000131765.73959.87. Epub 2004 May 24.
- Background: PubMed 9561995Grines CL, Marsalese DL, Brodie B, Griffin J, Donohue B, Costantini CR, Balestrini C, Stone G, Wharton T, Esente P, Spain M, Moses J, Nobuyoshi M, Ayres M, Jones D, Mason D, Sachs D, Grines LL, O'Neill W. Safety and cost-effectiveness of early discharge after primary angioplasty in low risk patients with acute myocardial infarction. PAMI-II Investigators. Primary Angioplasty in Myocardial Infarction. J Am Coll Cardiol. 1998 Apr;31(5):967-72. doi: 10.1016/s0735-1097(98)00031-x.
- Background: PubMed 20102876Kotowycz MA, Cosman TL, Tartaglia C, Afzal R, Syal RP, Natarajan MK. Safety and feasibility of early hospital discharge in ST-segment elevation myocardial infarction--a prospective and randomized trial in low-risk primary percutaneous coronary intervention patients (the Safe-Depart Trial). Am Heart J. 2010 Jan;159(1):117.e1-6. doi: 10.1016/j.ahj.2009.10.024.
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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.
Alessandro Sionis, MD principal investigator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early discharge (<72 h) and Conventional discharge in people with Myocardial Infarction, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 2 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 4 Jun 2013. 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 Spain. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality, new acute myocardial infarction, new unstable angina, heart failure, ventricular arrhythmias, stroke and severe bleeding. (time frame: 1 month). 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 NCT01868256, which also lists 4 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 4 Jun 2013.