Cardiometabolic Risk in Cardiac Rehab

NCT01985048 | Unknown

• 1 other identifier: R2013-3102
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

• 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Cardiometabolic biomarker risk factor

  Change from Baseline at 3 months

Secondary Outcomes (1)

• Major adverse cardiovascular events

  one year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Younger than 18 years old

Sponsors & Collaborators

• Health Diagnostic Laboratory, Inc.: lead

Study Sites (3)

Holy Spirit Hospital and Health Center

Camp Hill, Pennsylvania, 17011, United States

Location

Ephrata Community Hospital

Ephrata, Pennsylvania, 17522, United States

Location

Lancaster Heart & Vascular Institution, Cardiac Rehab

Lancaster, Pennsylvania, 17604, United States

Location

Related Publications (7)

• 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.

  PMID: 19555836 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.

  PMID: 21576654 BACKGROUND

• Hammill BG, Curtis LH, Schulman KA, Whellan DJ. Relationship between cardiac rehabilitation and long-term risks of death and myocardial infarction among elderly Medicare beneficiaries. Circulation. 2010 Jan 5;121(1):63-70. doi: 10.1161/CIRCULATIONAHA.109.876383. Epub 2009 Dec 21.

  PMID: 20026778 BACKGROUND

• Ghashghaei FE, Sadeghi M, Mostafavi S, Heidari H, Sarrafzadegan N. The effect of the cardiac rehabilitation program on obese and non-obese females with coronary heart disease. Adv Biomed Res. 2012;1:17. doi: 10.4103/2277-9175.96077. Epub 2012 May 11.

  PMID: 23210076 BACKGROUND

• Kubilius R, Jasiukeviciene L, Grizas V, Kubiliene L, Jakubseviciene E, Vasiliauskas D. The impact of complex cardiac rehabilitation on manifestation of risk factors in patients with coronary heart disease. Medicina (Kaunas). 2012;48(3):166-73.

  PMID: 22588350 BACKGROUND

• Martin SS, Gosch K, Kulkarni KR, Spertus JA, Mathews R, Ho PM, Maddox TM, Newby LK, Alexander KP, Wang TY. Modifiable factors associated with failure to attain low-density lipoprotein cholesterol goal at 6 months after acute myocardial infarction. Am Heart J. 2013 Jan;165(1):26-33.e3. doi: 10.1016/j.ahj.2012.10.005. Epub 2012 Nov 17.

  PMID: 23237130 BACKGROUND

• Gitt A, Jannowitz C, Karoff M, Karmann B, Horack M, Voller H. Treatment patterns and risk factor control in patients with and without metabolic syndrome in cardiac rehabilitation. Vasc Health Risk Manag. 2012;8:265-74. doi: 10.2147/VHRM.S28949. Epub 2012 Apr 24.

  PMID: 22566748 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood and Serum

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Roddy P Canosa, DO, FACC

  PRINCIPAL INVESTIGATOR

• Tina Davis, CRNP

  PRINCIPAL INVESTIGATOR

• James C. Lightfoot, M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 15, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: February 13, 2015

Record last verified: 2015-02

Locations

US (3)