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OpenTrials
Completed

NCT Number: NCT01645943

Invasive vs Conservative Strategies in Non-ST-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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Pujol i Trias, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary angiogram

Procedure

Routine coronary angiogram and revascularization if indicated

Primary outcomes

  1. All cause mortality, reinfarction or reasmission by cardiac cause

    Time frame: 1 year

Secondary outcomes

  1. Days alive out of the hospital

    Time frame: 1 year

  2. Bleeding

    Time frame: In-hospital (average= 1 week)

  3. Renal failure

    Time frame: In-hospital (average= 1 week)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: MOSCA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 20, 2012
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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