Cardiometabolic Risk in Cardiac Rehab | NCT01985048

Studies
Cardiometabolic Risk in Cardiac Rehab

NCT01985048

Sponsor

Health Diagnostic Laboratory, Inc.

Status

Unknown status

Last Update Posted

Feb 13, 2015Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

United States

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

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Mar 2015Estimated

Completion Date

Mar 2015Estimated

First Submitted Date

Nov 5, 2013

First Submission Date that Met QC Criteria

Nov 8, 2013

First Posted Date

Nov 15, 2013Estimated

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

Feb 12, 2015

Last Update Posted Date

Feb 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Primary Objectives:
- To characterize cardiometabolic risk factor profiles of patients entering cardiac rehab using traditional approaches (eg LDL-C) as well as a more comprehensive panel of cardiovascular and metabolic biomarkers. It is hypothesized that the comprehensive panel will identify further increased risk that would not have been detected using only traditional approaches. Specifically, it is hypothesized that a greater percentage of the cohort will be identified with "high risk" levels of LDL-P (>1100 nmol/L) and/or apoB (>80 mg/dL) than of LDL-C (>100 mg/dL). It is further hypothesized that the prevalence of elevated Lp(a) and elevated levels of inflammatory and insulin resistance markers will be higher in this cohort when compared to population norms (HDL, inc reference data).
- To assess improvements in laboratory and lifestyle risk factors and rate of goal attainment at completion of rehab (eg 3 months). This objective is primarily descriptive, and improvements in traditional risk factors (eg LDL-C) will be compared to existing published data. Improvements in non-traditional risk factors (eg LDL-P, insulin resistance markers) in a cardiac rehab population have not been extensively investigated.
- To determine which attributes at baseline best predicted recurrent events and re-hospitalizations assessed one year later.
Secondary/Developmental Objective:
- To inform and guide development of a subsequent study protocol designed to compare outcomes associated with biomarker-guided personalized treatment plans vs. standard of care in the cardiac rehab setting.

Detailed Description

This pilot study will characterize risk factors of patients as they enter cardiac rehab, track how comprehensive biomarker profiles change during the normal course of rehab, and associate biomarkers at baseline with MACE outcomes assessed one year later. Blood draws, vitals, and patient medical histories will be collected as subjects enter rehab and at the end of the rehab program. Major adverse cardiac events will be assessed via phone interview at 12 months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiometabolic biomarker risk factor		Change from Baseline at 3 months

Secondary Outcomes

Measure	Description	Time Frame
Major adverse cardiovascular events		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Known CAD/ IHD
Eligibility for cardiac rehab following an acute coronary event; either:
- ST elevation myocardial infarction
- Non ST elevation myocardial infarction
- Angina
- CABG

Exclusion Criteria:

Younger than 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Representative of the ethnic population of the areas served by the respective study sites.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Roddy P Canosa, DO, FACC		Principal Investigator
Tina Davis, CRNP		Principal Investigator
James C. Lightfoot, M.D.		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Holy Spirit Hospital and Health Center		Camp Hill	Pennsylvania	17011	United States
Ephrata Community Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19555836	Background	Suaya JA, Stason WB, Ades PA, Normand SL, Shepard DS. Cardiac rehabilitation and survival in older coronary patients. J Am Coll Cardiol. 2009 Jun 30;54(1):25-33. doi: 10.1016/j.jacc.2009.01.078.
21576654	Background	Goel K, Lennon RJ, Tilbury RT, Squires RW, Thomas RJ. Impact of cardiac rehabilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation. 2011 May 31;123(21):2344-52. doi: 10.1161/CIRCULATIONAHA.110.983536. Epub 2011 May 16.

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases