NCT01645943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

July 13, 2012

Last Update Submit

October 24, 2016

Conditions

Acute Coronary Syndrome

Keywords

Non-ST-elevation acute myocardial infarctionComorbidities

Outcome Measures

Primary Outcomes (1)

  • All cause mortality, reinfarction or reasmission by cardiac cause

    1 year

Secondary Outcomes (3)

  • Days alive out of the hospital

    1 year

  • Bleeding

    In-hospital (average= 1 week)

  • Renal failure

    In-hospital (average= 1 week)

Study Arms (2)

Conservative

NO INTERVENTION

Coronary angiogram only if recurrent ischemia or peristent heart failure or inducible ischemia in predischarge stress test if perfomed

Invasive

ACTIVE COMPARATOR

Routine coronary angiogram

Procedure: Coronary angiogram

Interventions

Coronary angiogramPROCEDURE

Routine coronary angiogram and revascularization if indicated

Invasive

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Pujol i Trias

Badalona, Barcelona, Spain

Location

Hopsital Clinic

Barcelona, Barcelona, Spain

Location

Hospital Virgen del Rosell

Cartagena, Murcia, Spain

Location

Hospital Clínico Universitario

Valencia, Valencia, 460140, Spain

Location

Hospital Valle Hebrón

Barcelona, Spain

Location

Hospital Virgen Arrixaca

Murcia, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27423981RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Juan Sanchis, Full Prof

    University of Valencia. University Clinic Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Medicine

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 20, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

ES(6)