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

October 24, 2016 updated by: Juan Sanchis, University of Valencia

Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Valle Hebrón
      • Barcelona, Spain
        • Hopsital Clinic
      • Murcia, Spain
        • Hospital Virgen Arrixaca
      • Valencia, Spain, 460140
        • Hospital Clínico Universitario
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Pujol i Trias
    • Murcia
      • Cartagena, Murcia, Spain
        • Hospital Virgen del Rosell

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative
Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed
Active Comparator: Invasive
Routine coronary angiogram
Procedure: Coronary angiogram
Routine coronary angiogram and revascularization if indicated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality, reinfarction or reasmission by cardiac cause
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Days alive out of the hospital
Time Frame: 1 year
1 year
Bleeding
Time Frame: In-hospital (average= 1 week)
In-hospital (average= 1 week)
Renal failure
Time Frame: In-hospital (average= 1 week)
In-hospital (average= 1 week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Juan Sanchis, Full Prof, University of Valencia. University Clinic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

July 13, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/ 01595

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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