Invasive vs Conservative Strategies in Non-ST-elevation Acute Coronary Syndrome and Comorbidities
NCT ID: NCT01645943
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
109 participants
INTERVENTIONAL
2012-01-31
2015-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conservative
Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed
No interventions assigned to this group
Invasive
Routine coronary angiogram
Coronary angiogram
Routine coronary angiogram and revascularization if indicated
Interventions
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Coronary angiogram
Routine coronary angiogram and revascularization if indicated
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior known non-revascularizable coronay disease
* Concomitant heart disease different to coronary disease
* Life expentancy \< 1 year
70 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
University of Valencia
OTHER
Responsible Party
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Juan Sanchis
Full Professor of Medicine
Principal Investigators
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Juan Sanchis, Full Prof
Role: PRINCIPAL_INVESTIGATOR
University of Valencia. University Clinic Hospital
Locations
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Hospital Pujol i Trias
Badalona, Barcelona, Spain
Hopsital Clinic
Barcelona, Barcelona, Spain
Hospital Virgen del Rosell
Cartagena, Murcia, Spain
Hospital Clínico Universitario
Valencia, Valencia, Spain
Hospital Valle Hebrón
Barcelona, , Spain
Hospital Virgen Arrixaca
Murcia, , Spain
Countries
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References
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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.
Other Identifiers
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11/ 01595
Identifier Type: -
Identifier Source: org_study_id