NCT03208153

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

4.5 years

First QC Date

June 30, 2017

Last Update Submit

March 23, 2022

Conditions

Non-ST Elevation Myocardial InfarctionFrail Elderly Syndrome

Outcome Measures

Primary Outcomes (2)

  • number of days alive out of the hospital

    number of days alive out of the hospital

    1 year

  • major adverse cardiac events

    cardiovascular death or myocardial infarction or revascularization

    1 year

Secondary Outcomes (6)

  • all-cause death

    1 and 3 years

  • cardiovascular death

    1 and 3 years

  • myocardial infarction

    1 and 3 years

  • rehospitalization for cardiac and extra-cardiac causes

    1 and 3 years

  • bleeding episodes

    1 and 3 years

  • +1 more secondary outcomes

Study Arms (2)

Invasive

EXPERIMENTAL

In-hospital routine coronary angiogram and revascularization if anatomically feasible

Procedure: Invasive

Conservative

ACTIVE COMPARATOR

In-hospital coronary angiogram only if poor clinical course

Procedure: Conservative

Interventions

InvasivePROCEDURE

Coronary angiogram and revascularization if anatomically feasible

Invasive
ConservativePROCEDURE

Conservative

Conservative

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Non-ST-elevation acute myocardial infarction
  • Age ≥70 years
  • Frailty criteria defined by =\>4 points in the Clinical Frailty Scale (Rockwood K CMAJ 2005).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Hospital

Valencia, 46010, Spain

Location

Related Publications (9)

  • 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.

    PMID: 22995877RESULT

  • Tegn 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.

    PMID: 26794722RESULT

  • Sanchis 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.

    PMID: 27423981RESULT

  • Nunez 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.

    PMID: 27870976RESULT

  • Sanchis 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.

    PMID: 28389067RESULT

  • Sanchis 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.

    PMID: 39922692DERIVED

  • Sanchis 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.

    PMID: 38446482DERIVED

  • Sanchis 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.

    PMID: 36877502DERIVED

  • Sanchis 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.

    PMID: 29525724DERIVED

MeSH Terms

Conditions

Non-ST Elevated Myocardial Infarction

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

June 30, 2017

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

No plan

Locations

ES(1)