Non-ST Elevation Myocardial InfarctionMOSCA-FRAILNCT03208153
the Invasive and Conservative Strategies in Elderly Frail Patients With Non-STEMI
A study testing Invasive and Conservative in people with Non-ST Elevation Myocardial Infarction and Frail Elderly Syndrome, run by University of Valencia at 1 site in Spain.
Trial summary
The role of a routine invasive strategy in frail patients with non-ST-segment elevation acute myocardial infarction is currently uncertain. We hypothesize that a routine invasive strategy will improve outcomes. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Non-ST Elevation Myocardial Infarction, Frail Elderly Syndrome
- What is being tested?
- Invasive and Conservative
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 167 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2017to 31 Dec 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Non-ST-elevation acute myocardial infarction
- Age ≥70 years
- Frailty criteria defined by =>4 points in the Clinical Frailty Scale (Rockwood K CMAJ 2005).
Who cannot join
- Prior known non-revascularizable coronary artery disease
- Significant concomitant non-ischemic heart disease (i.e. severe heart valve disease, hypertrophic cardiomyopathy…)
- Unable to understand/sign informed consent
- Life expectancy <12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison Between the Invasive and Conservative Strategies in Elderly Frail Patients With Non-ST Elevation Myocardial Infarction: The MOSCA-FRAIL Clinical Trial
The role of a routine invasive strategy in frail patients with non-ST-segment elevation acute myocardial infarction is currently uncertain. We hypothesize that a routine invasive strategy will improve outcomes. The aim of the trial is to evaluate the efficacy and safety of a routine invasive strategy in increasing the number of days alive at home during the first year and improving cardiovascular outcomes.
Read the detailed description
There is a lack of evidence for the best management of frail patients with non-ST-elevation myoardial infaarction (NSTEMI). Clinical practice guidelines recommend a routine invasive strategy in NSTEMI in the majority of patients (Roffi Eur Heart 2016). Nevertheless, invasive management is underused in frail and patients with comorbidity (Ekerstad Circulation 2011, Sanchis Mayo Clin Proceed 2011, Graham Can J Cardiol 2013,). Furthermore, frail patients undergoing coronary angiography have lower revascularisation rates than non frail counterparts (Ekerstad Circulation 2011, Graham Can J Cardiol 2013). This may be, in part, a reflection of the more complex coronary artery disease, more frequently presenting left main, three vessel disease or proximal coronary artery disease, which may not be amenable to PCI (Singh Circ Cardiovasc Qualit Outco 2011). However, it is also possible that lower rates reflect an aversion to a perceived risk of the intervention in the frail, whereby those with potential to gain benefit may have been deemed not appropriate for coronary intervention. After PCI or cardiac surgery, frailty and comorbidity are associated with adverse long-term outcomes (Singh CircQualitOutco 2011, SundermanEur J Cardio-thoracic Surgery 2011). Comorbid patients, however, could benefit the most from in-hospital revascularization in NSTEMI (Bauer et al Eur Heart J 2007, Palau Clin Cardiol 2012).
A few studies addressed the role of invasive strategy in elderly patients. A routine invasive strategy was not statistically superior to a selective invasive strategy in elderly patients with NSTEMI (Savonito JACC CIV 2012) but the study was underpowered due to the small sample size. The After Eighty randomized trial was a proper-sized study which included patients >80 years with NSTEMI and demonstrated the benefit of the invasive strategy in reducing the composite endpoint of death or cardiovascular events at 1.5 years (Tegn Lancet 2016). It is worth noting that no patient underwent cardiac catheterization under any circumstance in the conservative arm of that study. Furthermore, only 23% of the potential candidates for inclusion were finally randomized, suggesting a bias towards lower risk patients, a very restrictive approach. Recently, the MOSCA randomized trial evaluated the efficacy of an invasive strategy in elderly patients with NSTEMI and comorbidities (Sanchis Eur J Intern Med 2016). Although this was a small trial, the invasive strategy reduced the probability of death or ischemic events at 3 months. This benefit, nonetheless, vanished at 2.5-years follow-up. No clinical trials specifically designed to investigate the management of frail patients in NSTEMI have been conducted so far. In fact, frail patients have usually been excluded from randomized clinical trials. The TRILOGY-ACS trial, for instance, included a remarkably low rate (4.7%) of frail patients (White, Eur Heart J ACC 2016).
On the other hand, while most of the studies mainly focus on death, myocardial infarction, stroke, need for revascularisation or rehospitalisation, patients are also willing to recover an independent life and return to their usual place for living. The presence of geriatric syndromes (including frailty, cognitive impairment, severe dependence and depression) is not only associated with worse clinical outcomes but with a greater risk of functional decline and need for new social help, that is an increased level of dependence. This has an important impact on the patient quality of life and psychological wellbeing but also frequently becomes a heavy social and economic burden for patients and families. Therefore, one of the real challenges in the management of ACS in very old patients is the prevention of dependence. In this sense, the use of new outcomes especially addressed to measure level of independence and quality of life is especially important (Montilla I, Heart Lung Circ 2016).
The role of a routine invasive strategy in frail patients is currently uncertain. We hypothesize that a routine invasive strategy in frail patients with NSTEMI will improve outcomes. The aim of the trial is to evaluate the efficacy and safety of a routine invasive strategy in increasing the number of days alive at home during the first year and improving cardiovascular outcomes. A prespecified subgroup analysis will be conducted according to comorbidities and Charlson index
- Being tested
- Invasive, Conservative
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InvasiveProcedure or surgery
Coronary angiogram and revascularization if anatomically feasible
ConservativeProcedure or surgery
Conservative
| Study group | Role | What they receive |
|---|---|---|
| Invasive | Experimental | In-hospital routine coronary angiogram and revascularization if anatomically feasible Receives: Procedure: Invasive |
| Conservative | Active comparator | In-hospital coronary angiogram only if poor clinical course Receives: Procedure: Conservative |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of days alive out of the hospital
number of days alive out of the hospital
Measured: 1 year
major adverse cardiac events
cardiovascular death or myocardial infarction or revascularization
Measured: 1 year
Secondary outcomes (6)
all-cause death
Measured: 1 and 3 years
cardiovascular death
Measured: 1 and 3 years
myocardial infarction
Measured: 1 and 3 years
rehospitalization for cardiac and extra-cardiac causes
Measured: 1 and 3 years
bleeding episodes
Measured: 1 and 3 years
stroke
Measured: 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2017
- Study start30 Jun 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Non-ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Cardiology, Instituto de Investigacion Sanitaria INCLIVA
- Responsible party
- Principal investigator, Juan Sanchis, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03208153
- Sponsor's protocol ID
- MOSCA-II
- Acronym
- MOSCA-FRAIL
- Status last verified
- Mar 2022
- First submitted
- 30 Jun 2017
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.
PubMed 22995877Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.
PubMed 26794722Sanchis J, Nunez E, Barrabes JA, Marin F, Consuegra-Sanchez L, Ventura S, Valero E, Roque M, Bayes-Genis A, Del Blanco BG, Degano I, Nunez J. Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST elevation myocardial infarction. Eur J Intern Med. 2016 Nov;35:89-94. doi: 10.1016/j.ejim.2016.07.003. Epub 2016 Aug 8.
PubMed 27423981Nunez J, Ruiz V, Bonanad C, Minana G, Garcia-Blas S, Valero E, Nunez E, Sanchis J. Percutaneous coronary intervention and recurrent hospitalizations in elderly patients with non ST-segment acute coronary syndrome: The role of frailty. Int J Cardiol. 2017 Feb 1;228:456-458. doi: 10.1016/j.ijcard.2016.11.151. Epub 2016 Nov 10. No abstract available.
PubMed 27870976Sanchis J, Ruiz V, Bonanad C, Valero E, Ruescas-Nicolau MA, Ezzatvar Y, Sastre C, Garcia-Blas S, Mollar A, Bertomeu-Gonzalez V, Minana G, Nunez J. Prognostic Value of Geriatric Conditions Beyond Age After Acute Coronary Syndrome. Mayo Clin Proc. 2017 Jun;92(6):934-939. doi: 10.1016/j.mayocp.2017.01.018. Epub 2017 Apr 25.
PubMed 28389067Sanchis J, Bueno H, Marti Sanchez D, Martinez-Selles M, Diez Villanueva P, Barrabes JA, Marin F, Villa A, Sanmartin Fernandez M, Llibre C, Sionis A, Elizaga J, Alfonso F, Nunez E, Nunez J, Kunadian V, Ariza-Sole A. Effects of routine invasive management on reinfarction risk in older adults with frailty and non-ST-segment elevation myocardial infarction: a subanalysis of a randomised clinical trial. Heart. 2025 Jul 28;111(16):786-792. doi: 10.1136/heartjnl-2024-325254.
PubMed 39922692Sanchis J, Bueno H, Garcia-Blas S, Alegre O, Marti D, Martinez-Selles M, Dominguez-Perez L, Diez-Villanueva P, Barrabes JA, Marin F, Villa A, Sanmartin M, Llibre C, Sionis A, Carol A, Fernandez-Cisnal A, Calvo E, Morales MJ, Elizaga J, Gomez I, Alfonso F, Garcia Del Blanco B, Formiga F, Nunez E, Nunez J, Ariza-Sole A. Invasive Treatment Strategy in Adults With Frailty and Non-ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240809. doi: 10.1001/jamanetworkopen.2024.0809.
PubMed 38446482Sanchis J, Bueno H, Minana G, Guerrero C, Marti D, Martinez-Selles M, Dominguez-Perez L, Diez-Villanueva P, Barrabes JA, Marin F, Villa A, Sanmartin M, Llibre C, Sionis A, Carol A, Garcia-Blas S, Calvo E, Morales Gallardo MJ, Elizaga J, Gomez-Blazquez I, Alfonso F, Garcia Del Blanco B, Nunez J, Formiga F, Ariza-Sole A. Effect of Routine Invasive vs Conservative Strategy in Older Adults With Frailty and Non-ST-Segment Elevation Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA Intern Med. 2023 May 1;183(5):407-415. doi: 10.1001/jamainternmed.2023.0047.
PubMed 36877502Sanchis J, Ariza-Sole A, Abu-Assi E, Alegre O, Alfonso F, Barrabes JA, Baz JA, Carol A, Diez Villanueva P, Garcia Del Blanco B, Elizaga J, Fernandez E, Garcia Del Egido A, Garcia Picard J, Gomez Blazquez I, Gomez Hospital JA, Hernandez-Antolin R, Llibre C, Marin F, Marti Sanchez D, Martin R, Martinez Selles M, Minana G, Morales Gallardo MJ, Nunez J, Perez de Prado A, Pinar E, Sanmartin M, Sionis A, Villa A, Marrugat J, Bueno H. Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design. Rev Esp Cardiol (Engl Ed). 2019 Feb;72(2):154-159. doi: 10.1016/j.rec.2018.02.007. Epub 2018 Mar 7. English, Spanish.
PubMed 29525724
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison Between the Invasive and Conservative Strategies in Elderly Frail Patients With Non-ST Elevation Myocardial Infarction: The MOSCA-FRAIL Clinical Trial
- ClinicalTrials.gov ID
- NCT03208153
- Acronym / sponsor ID
- MOSCA-FRAIL / MOSCA-II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Spanish Society of Cardiology, Instituto de Investigacion Sanitaria INCLIVA
- Study start
- 30 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 5 Jul 2017 (actual)
- 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 role of a routine invasive strategy in frail patients with non-ST-segment elevation acute myocardial infarction is currently uncertain. We hypothesize that a routine invasive strategy will improve outcomes. The aim of the trial is to evaluate the efficacy and safety of a routine invasive strategy in increasing the number of days alive at home during the first year and improving cardiovascular outcomes.
Detailed description
There is a lack of evidence for the best management of frail patients with non-ST-elevation myoardial infaarction (NSTEMI). Clinical practice guidelines recommend a routine invasive strategy in NSTEMI in the majority of patients (Roffi Eur Heart 2016). Nevertheless, invasive management is underused in frail and patients with comorbidity (Ekerstad Circulation 2011, Sanchis Mayo Clin Proceed 2011, Graham Can J Cardiol 2013,). Furthermore, frail patients undergoing coronary angiography have lower revascularisation rates than non frail counterparts (Ekerstad Circulation 2011, Graham Can J Cardiol 2013). This may be, in part, a reflection of the more complex coronary artery disease, more frequently presenting left main, three vessel disease or proximal coronary artery disease, which may not be amenable to PCI (Singh Circ Cardiovasc Qualit Outco 2011). However, it is also possible that lower rates reflect an aversion to a perceived risk of the intervention in the frail, whereby those with potential to gain benefit may have been deemed not appropriate for coronary intervention. After PCI or cardiac surgery, frailty and comorbidity are associated with adverse long-term outcomes (Singh CircQualitOutco 2011, SundermanEur J Cardio-thoracic Surgery 2011). Comorbid patients, however, could benefit the most from in-hospital revascularization in NSTEMI (Bauer et al Eur Heart J 2007, Palau Clin Cardiol 2012).
A few studies addressed the role of invasive strategy in elderly patients. A routine invasive strategy was not statistically superior to a selective invasive strategy in elderly patients with NSTEMI (Savonito JACC CIV 2012) but the study was underpowered due to the small sample size. The After Eighty randomized trial was a proper-sized study which included patients >80 years with NSTEMI and demonstrated the benefit of the invasive strategy in reducing the composite endpoint of death or cardiovascular events at 1.5 years (Tegn Lancet 2016). It is worth noting that no patient underwent cardiac catheterization under any circumstance in the conservative arm of that study. Furthermore, only 23% of the potential candidates for inclusion were finally randomized, suggesting a bias towards lower risk patients, a very restrictive approach. Recently, the MOSCA randomized trial evaluated the efficacy of an invasive strategy in elderly patients with NSTEMI and comorbidities (Sanchis Eur J Intern Med 2016). Although this was a small trial, the invasive strategy reduced the probability of death or ischemic events at 3 months. This benefit, nonetheless, vanished at 2.5-years follow-up. No clinical trials specifically designed to investigate the management of frail patients in NSTEMI have been conducted so far. In fact, frail patients have usually been excluded from randomized clinical trials. The TRILOGY-ACS trial, for instance, included a remarkably low rate (4.7%) of frail patients (White, Eur Heart J ACC 2016).
On the other hand, while most of the studies mainly focus on death, myocardial infarction, stroke, need for revascularisation or rehospitalisation, patients are also willing to recover an independent life and return to their usual place for living. The presence of geriatric syndromes (including frailty, cognitive impairment, severe dependence and depression) is not only associated with worse clinical outcomes but with a greater risk of functional decline and need for new social help, that is an increased level of dependence. This has an important impact on the patient quality of life and psychological wellbeing but also frequently becomes a heavy social and economic burden for patients and families. Therefore, one of the real challenges in the management of ACS in very old patients is the prevention of dependence. In this sense, the use of new outcomes especially addressed to measure level of independence and quality of life is especially important (Montilla I, Heart Lung Circ 2016).
The role of a routine invasive strategy in frail patients is currently uncertain. We hypothesize that a routine invasive strategy in frail patients with NSTEMI will improve outcomes. The aim of the trial is to evaluate the efficacy and safety of a routine invasive strategy in increasing the number of days alive at home during the first year and improving cardiovascular outcomes. A prespecified subgroup analysis will be conducted according to comorbidities and Charlson index
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive | Experimental | Procedure: InvasiveIn-hospital routine coronary angiogram and revascularization if anatomically feasible |
| Conservative | Active comparator | Procedure: ConservativeIn-hospital coronary angiogram only if poor clinical course |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Non-ST-elevation acute myocardial infarction
- Age ≥70 years
- Frailty criteria defined by =>4 points in the Clinical Frailty Scale (Rockwood K CMAJ 2005).
Key exclusion criteria (4 listed)
- Prior known non-revascularizable coronary artery disease
- Significant concomitant non-ischemic heart disease (i.e. severe heart valve disease, hypertrophic cardiomyopathy…)
- Unable to understand/sign informed consent
- Life expectancy <12 months
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 |
|---|---|---|
| InvasiveCoronary angiogram and revascularization if anatomically feasible | Procedure or surgery | Invasive |
| ConservativeConservative | Procedure or surgery | Conservative |
Primary outcome
number of days alive out of the hospital
Time frame: 1 year
number of days alive out of the hospital
major adverse cardiac events
Time frame: 1 year
cardiovascular death or myocardial infarction or revascularization
6 secondary outcomes
all-cause death
Time frame: 1 and 3 years
cardiovascular death
Time frame: 1 and 3 years
myocardial infarction
Time frame: 1 and 3 years
rehospitalization for cardiac and extra-cardiac causes
Time frame: 1 and 3 years
bleeding episodes
Time frame: 1 and 3 years
stroke
Time frame: 1 and 3 years
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 25 Mar 2022.
- Results publication: PubMed 22995877Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.
- Results publication: PubMed 26794722Tegn N, Abdelnoor M, Aaberge L, Endresen K, Smith P, Aakhus S, Gjertsen E, Dahl-Hofseth O, Ranhoff AH, Gullestad L, Bendz B; After Eighty study investigators. Invasive versus conservative strategy in patients aged 80 years or older with non-ST-elevation myocardial infarction or unstable angina pectoris (After Eighty study): an open-label randomised controlled trial. Lancet. 2016 Mar 12;387(10023):1057-1065. doi: 10.1016/S0140-6736(15)01166-6. Epub 2016 Jan 13.
- Results publication: PubMed 27423981Sanchis J, Nunez E, Barrabes JA, Marin F, Consuegra-Sanchez L, Ventura S, Valero E, Roque M, Bayes-Genis A, Del Blanco BG, Degano I, Nunez J. Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST elevation myocardial infarction. Eur J Intern Med. 2016 Nov;35:89-94. doi: 10.1016/j.ejim.2016.07.003. Epub 2016 Aug 8.
- Results publication: PubMed 27870976Nunez J, Ruiz V, Bonanad C, Minana G, Garcia-Blas S, Valero E, Nunez E, Sanchis J. Percutaneous coronary intervention and recurrent hospitalizations in elderly patients with non ST-segment acute coronary syndrome: The role of frailty. Int J Cardiol. 2017 Feb 1;228:456-458. doi: 10.1016/j.ijcard.2016.11.151. Epub 2016 Nov 10. No abstract available.
- Results publication: PubMed 28389067Sanchis J, Ruiz V, Bonanad C, Valero E, Ruescas-Nicolau MA, Ezzatvar Y, Sastre C, Garcia-Blas S, Mollar A, Bertomeu-Gonzalez V, Minana G, Nunez J. Prognostic Value of Geriatric Conditions Beyond Age After Acute Coronary Syndrome. Mayo Clin Proc. 2017 Jun;92(6):934-939. doi: 10.1016/j.mayocp.2017.01.018. Epub 2017 Apr 25.
- Derived from this study: PubMed 39922692Sanchis J, Bueno H, Marti Sanchez D, Martinez-Selles M, Diez Villanueva P, Barrabes JA, Marin F, Villa A, Sanmartin Fernandez M, Llibre C, Sionis A, Elizaga J, Alfonso F, Nunez E, Nunez J, Kunadian V, Ariza-Sole A. Effects of routine invasive management on reinfarction risk in older adults with frailty and non-ST-segment elevation myocardial infarction: a subanalysis of a randomised clinical trial. Heart. 2025 Jul 28;111(16):786-792. doi: 10.1136/heartjnl-2024-325254.
- Derived from this study: PubMed 38446482Sanchis J, Bueno H, Garcia-Blas S, Alegre O, Marti D, Martinez-Selles M, Dominguez-Perez L, Diez-Villanueva P, Barrabes JA, Marin F, Villa A, Sanmartin M, Llibre C, Sionis A, Carol A, Fernandez-Cisnal A, Calvo E, Morales MJ, Elizaga J, Gomez I, Alfonso F, Garcia Del Blanco B, Formiga F, Nunez E, Nunez J, Ariza-Sole A. Invasive Treatment Strategy in Adults With Frailty and Non-ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Mar 4;7(3):e240809. doi: 10.1001/jamanetworkopen.2024.0809.
- Derived from this study: PubMed 36877502Sanchis J, Bueno H, Minana G, Guerrero C, Marti D, Martinez-Selles M, Dominguez-Perez L, Diez-Villanueva P, Barrabes JA, Marin F, Villa A, Sanmartin M, Llibre C, Sionis A, Carol A, Garcia-Blas S, Calvo E, Morales Gallardo MJ, Elizaga J, Gomez-Blazquez I, Alfonso F, Garcia Del Blanco B, Nunez J, Formiga F, Ariza-Sole A. Effect of Routine Invasive vs Conservative Strategy in Older Adults With Frailty and Non-ST-Segment Elevation Acute Myocardial Infarction: A Randomized Clinical Trial. JAMA Intern Med. 2023 May 1;183(5):407-415. doi: 10.1001/jamainternmed.2023.0047.
- Derived from this study: PubMed 29525724Sanchis J, Ariza-Sole A, Abu-Assi E, Alegre O, Alfonso F, Barrabes JA, Baz JA, Carol A, Diez Villanueva P, Garcia Del Blanco B, Elizaga J, Fernandez E, Garcia Del Egido A, Garcia Picard J, Gomez Blazquez I, Gomez Hospital JA, Hernandez-Antolin R, Llibre C, Marin F, Marti Sanchez D, Martin R, Martinez Selles M, Minana G, Morales Gallardo MJ, Nunez J, Perez de Prado A, Pinar E, Sanmartin M, Sionis A, Villa A, Marrugat J, Bueno H. Invasive Versus Conservative Strategy in Frail Patients With NSTEMI: The MOSCA-FRAIL Clinical Trial Study Design. Rev Esp Cardiol (Engl Ed). 2019 Feb;72(2):154-159. doi: 10.1016/j.rec.2018.02.007. Epub 2018 Mar 7. English, Spanish.
- Individual participant dataSharing planned: No. No plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invasive and Conservative in people with Non-ST Elevation Myocardial Infarction and Frail Elderly Syndrome, run by University of Valencia 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 3 inclusion and 4 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 25 Mar 2022. 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?
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?
number of days alive out of the hospital (time frame: 1 year). The study lists 2 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 NCT03208153, which also lists 9 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 25 Mar 2022.