Cardiometabolic Risk in Cardiac Rehab
2015年2月12日 更新者:Health Diagnostic Laboratory, Inc.
Cardiometabolic Risk in the Setting of Cardiac Rehabilitation
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.
研究概览
地位
未知
条件
详细说明
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.
研究类型
观察性的
注册 (预期的)
500
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Pennsylvania
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Camp Hill、Pennsylvania、美国、17011
- Holy Spirit Hospital and Health Center
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Ephrata、Pennsylvania、美国、17522
- Ephrata Community Hospital
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Lancaster、Pennsylvania、美国、17604
- Lancaster Heart & Vascular Institution, Cardiac Rehab
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Representative of the ethnic population of the areas served by the respective study sites.
描述
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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Cardiometabolic biomarker risk factor
大体时间:Change from Baseline at 3 months
|
Change from Baseline at 3 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Major adverse cardiovascular events
大体时间:one year
|
one year
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Roddy P Canosa, DO, FACC
- 首席研究员:Tina Davis, CRNP
- 首席研究员:James C. Lightfoot, M.D.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年10月1日
初级完成 (预期的)
2015年3月1日
研究完成 (预期的)
2015年3月1日
研究注册日期
首次提交
2013年11月5日
首先提交符合 QC 标准的
2013年11月8日
首次发布 (估计)
2013年11月15日
研究记录更新
最后更新发布 (估计)
2015年2月13日
上次提交的符合 QC 标准的更新
2015年2月12日
最后验证
2015年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.