Clinical trial NCT01645943: Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities
Official title: Randomized Comparison Between Invasive and Conservative Strategies in Patients With Non-ST-segment Elevation Acute Coronary Syndrome and Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: Non-ST-elevation acute myocardial infarction
Comorbidities
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2012-07-20
Enrollment: 109
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All cause mortality, reinfarction or reasmission by cardiac cause
timeFrame: 1 year
Secondary outcomes:
measure: Days alive out of the hospital
timeFrame: 1 year
measure: Bleeding
timeFrame: In-hospital (average= 1 week)
measure: Renal failure
timeFrame: In-hospital (average= 1 week)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Pujol i Trias
state: Barcelona
city: Cartagena
country: Spain
facility: Hospital Virgen del Rosell
state: Murcia
city: Barcelona
country: Spain
facility: Hopsital Clinic
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón
city: Murcia
country: Spain
facility: Hospital Virgen Arrixaca
city: Valencia
country: Spain
facility: Hospital Clínico Universitario
Study officials:
affiliation: University of Valencia. University Clinic Hospital
name: Juan Sanchis, Full Prof
role: PRINCIPAL_INVESTIGATOR
References:
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.