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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01645943

Acronym

MOSCA

Enrollment

109

Registered

2012-07-20

Start date

2012-01-31

Completion date

2015-03-31

Last updated

2016-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome

Keywords

Non-ST-elevation acute myocardial infarction, Comorbidities

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.

Interventions

PROCEDURECoronary angiogram

Routine coronary angiogram and revascularization if indicated

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
All cause mortality, reinfarction or reasmission by cardiac cause	1 year

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026