Frailty as an INstrument for Evaluation of Elderly Patien... | NCT01049997

Studies
Frailty as an INstrument for Evaluation of Elderly Patients With Non ST Elevation Myocardial Infarction (NSTEMI)

NCT01049997

Sponsor

Linkoeping University

Status

Completed

Last Update Posted

Mar 31, 2015Estimated

Enrollment

307Actual

Phase

Not provided

Conditions

Non ST Elevation Myocardial Infarction (NSTEMI)
Frailty

Interventions

Not provided

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Jun 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 14, 2010

First Posted Date

Jan 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2015

Last Update Posted Date

Mar 31, 2015Estimated

Name	Class
Medical Research Council	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to describe patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.

Detailed Description

The term frailty denotes a multi-dimensional syndrome characterized by increased vulnerability and decreased physiologic reserves. Frailty stratification predicts a patient's risk of death and need for institutional care. The construct is well validated, but there is not one single accepted operational definition. The CSHA Clinical Frailty Scale (CFS) is a 7-point scale relying on clinical judgement. It is a global clinical measure of biological age, and it mixes co-morbidity, disability and cognitive impairment.Though frailty instruments so far mainly have been used in a geriatric context, it has been pointed out as relevant for cardiologic patients as well, e.g. regarding risk stratification for elderly patients with NSTEMI. The purpose of this study is to describe patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI) especially regarding the following variables: cardiovascular risk, co-morbidity and frailty. The investigators hypothesize that the degree of frailty influences the benefit from coronary angiography and the possible invasive treatment which can follow.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

307Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSTEMI75+		Patients, 75 years old or older, with Non ST Elevation Myocardial Infarction (NSTEMI)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The composite of death from any cause, myocardial infarction, revascularization due to ischemia, hospitalization from any cause, major bleeding, stroke/TIA and need for dialysis by one month after inclusion.		One month after inclusion

Secondary Outcomes

Measure	Description	Time Frame
The composite of major bleeding, stroke/TIA and need for dialysis by one month after inclusion.		One month after inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients, 75 years old or older, with diagnosed NSTEMI, and cared for at one of the following hospital care units: cardiology, acute medicine, geriatrics, other internal medicine unit.

Exclusion Criteria:

Not willing to participate.
Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Consecutive evaluable patients, 75 years old or older, with diagnosed NSTEMI, and cared for at one of the following hospital care units in the University Hospital of Linköping and the County Hospitals in Trollhättan (NÄL-Uddevalla) and Jönköping (Ryhov): cardiology, acute medicine, geriatrics, other internal medicine unit.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Niklas G Ekerstad, MD	Linkoeping University, Sandbäcksgatan 7, 58183 Linkoeping, Sweden	Principal Investigator
Joakim Alfredsson, PhD	Department of Cardiology, University Hospital of Linkoeping, 58183 Linkoeping, Sweden	Principal Investigator
Marcus Lindenberger, PhD	Department of Cardiology, County Hospital Ryhov, 551 85 Joenkoeping, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Center for Medical Technology Assessment/IMH, Linkoeping University		Linköping	Östergötland County	58183	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D000072658	Non-ST Elevated Myocardial Infarction
D000073496	Frailty

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided