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

Acute Coronary Syndrome Clinical Trial

— MOSCA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645943
• Other study ID #: 11/ 01595
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2012
• Last updated: October 24, 2016
• Start date: January 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Procedure:
• Coronary angiogram
Routine coronary angiogram and revascularization if indicated

Locations

Country	Name	City	State
Spain	Hospital Pujol i Trias	Badalona	Barcelona
Spain	Hopsital Clinic	Barcelona
Spain	Hospital Valle Hebrón	Barcelona
Spain	Hospital Virgen del Rosell	Cartagena	Murcia
Spain	Hospital Virgen Arrixaca	Murcia
Spain	Hospital Clínico Universitario	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Sanchis J, Núñez E, Barrabés JA, Marín F, Consuegra-Sánchez L, Ventura S, Valero E, Roqué M, Bayés-Genís A, Del Blanco BG, Dégano I, Núñez J. Randomized comparison between the invasive and conservative strategies in comorbid elderly patients with non-ST e — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality, reinfarction or reasmission by cardiac cause		1 year	Yes
Secondary	Days alive out of the hospital		1 year	No
Secondary	Bleeding		In-hospital (average= 1 week)	No
Secondary	Renal failure		In-hospital (average= 1 week)	No