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Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities (MOSCA)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Coronary angiogram
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Non-ST-elevation acute myocardial infarction, Comorbidities

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age =>70 years old
  • Angina chest pain
  • Troponin elevation
  • At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR <45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold>2 or ambulatory oxigen therapy). Anemia (Hb =<11 g/dl)

Exclusion Criteria:

  • Dynamic ST changes (=>1 mm) in the initial ECG
  • Prior known non-revascularizable coronay disease
  • Concomitant heart disease different to coronary disease
  • Life expentancy < 1 year

Sites / Locations

  • Hospital Pujol i Trias
  • Hospital Virgen del Rosell
  • Hopsital Clinic
  • Hospital Valle Hebrón
  • Hospital Virgen Arrixaca
  • Hospital Clínico Universitario

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Conservative

Invasive

Arm Description

Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed

Routine coronary angiogram

Outcomes

Primary Outcome Measures

All cause mortality, reinfarction or reasmission by cardiac cause

Secondary Outcome Measures

Days alive out of the hospital
Bleeding
Renal failure

Full Information

First Posted
July 13, 2012
Last Updated
October 24, 2016
Sponsor
University of Valencia
Collaborators
Instituto de Salud Carlos III
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1. Study Identification

Unique Protocol Identification Number
NCT01645943
Brief Title
Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities
Acronym
MOSCA
Official Title
Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia
Collaborators
Instituto de Salud Carlos III

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The guidelines of clinical practice, based on the randomized studies, recommend an invasive strategy in non-ST elevation acute coronary syndrome (NSTEACS). However, patients with comorbidities are excluded from the randomized studies and the observational registries showthat patients with comoribidities undergo fewer cardiac catheterizations. The aim is to investigate the benefit of the invasive strategy in patients with NSTEACS and comorbidities. Patients hospitalized with NSTEACS, older than 70 years and with significant comorbidities, will be included. The latter will be defined as at least 2 of the following: peripheral artery disease, cerebral vascular disease, dementia, chronic pulmonary disease, chronic renal failure and anemia. The included patients will be randomized to an invasive (routine coronary angiogram) or conservative (coronary angiogram only if recurrent or inducible ischemia) strategy. All patients will receive medical treatment according to current recommendations. The main outcome will be death, reinfarction or readmissions by heart cause at one-year follow-up. The hypothesis is that an invasive strategy will improve prognosis in patients with NSTEACS and comorbidities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Non-ST-elevation acute myocardial infarction, Comorbidities

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative
Arm Type
No Intervention
Arm Description
Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed
Arm Title
Invasive
Arm Type
Active Comparator
Arm Description
Routine coronary angiogram
Intervention Type
Procedure
Intervention Name(s)
Coronary angiogram
Intervention Description
Routine coronary angiogram and revascularization if indicated
Primary Outcome Measure Information:
Title
All cause mortality, reinfarction or reasmission by cardiac cause
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Days alive out of the hospital
Time Frame
1 year
Title
Bleeding
Time Frame
In-hospital (average= 1 week)
Title
Renal failure
Time Frame
In-hospital (average= 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age =>70 years old Angina chest pain Troponin elevation At least 2 of the following comorbidities: A) Documented peripheral artery disease. B)Renal filaure (GFR <45 ml/min/m2). C) Neurological disease with permanent deficit. D) Dementia (Pfeiffer test). E) Chronic pulmonary disease (Gold>2 or ambulatory oxigen therapy). Anemia (Hb =<11 g/dl) Exclusion Criteria: Dynamic ST changes (=>1 mm) in the initial ECG Prior known non-revascularizable coronay disease Concomitant heart disease different to coronary disease Life expentancy < 1 year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Sanchis, Full Prof
Organizational Affiliation
University of Valencia. University Clinic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Pujol i Trias
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Virgen del Rosell
City
Cartagena
State/Province
Murcia
Country
Spain
Facility Name
Hopsital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital Valle Hebrón
City
Barcelona
Country
Spain
Facility Name
Hospital Virgen Arrixaca
City
Murcia
Country
Spain
Facility Name
Hospital Clínico Universitario
City
Valencia
ZIP/Postal Code
460140
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27423981
Citation
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.
Results Reference
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Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities

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