Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI

Coronary Heart Disease Clinical Trial

Official title:

A Single Centre, Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02351674
• Other study ID #: ESR-14-10413
• Status: Not yet recruiting
• Phase: N/A
• First received: January 27, 2015
• Last updated: January 27, 2015
• Start date: January 2015

Study information

• Verified date: January 2015
• Source: Chinese PLA General Hospital
• Contact: Dandan Li, M.D.
• Phone: +86 10 55499135
• Email: ldd301heart[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The trial is a single centre, retrospective cohort, non-interventional study to be conducted in the department of cardiology, Chinese PLA General Hospital, Beijing, China. To evaluate the link between mean perioperative clinical heart rate and short-term composite outcomes during PCI among local CHD patients.

Description:

The study requires those data including subjects aged from 20 to 80 year-old, diagnosed as coronary heart disease with records on mean clinical heart rate during PCI from 2009.1 to 2014.5 in the database from the department of cardiology, Chinese PLA General Hospital, Beijing. All 15,000 subjects' related data from the database will be collected.Once selected, 15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean clinical resting heart rate during PCI. Group 1 will be defined as subjects' mean clinical resting heart rate ≤70 BPM, which will be set as baseline. Group 2 will be defined as subjects' mean clinical resting heart rate between 71 to 80 BPM. Group 3 will be defined as subjects' mean clinical resting heart rate between 81 to 90 BPM. Group 4 will be defined as subjects' mean clinical resting heart rate >90 BPM. The primary endpoint is to determine the link between the mean perioperative heart rate and short-term outcomes during PCI among local CHD patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15000
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients consecutive enrolled in Chinese PLA General Hospital from January 2009 to May 2014

• Diagnosed as coronary heart disease with records on mean clinical heart rate during PCI .

Exclusion Criteria:

• Inferior wall myocardial infarction (MI) history or/and acute inferior wall MI patients;

• Dead within 3 days after admit into wards;

• LVEF<30%;

• Install a permanent pacemaker patients.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dandan Li

References & Publications (4)

Anselmino M, Ohrvik J, Rydén L; Euro Heart Survey Investigators. Resting heart rate in patients with stable coronary artery disease and diabetes: a report from the euro heart survey on diabetes and the heart. Eur Heart J. 2010 Dec;31(24):3040-5. doi: 10.1093/eurheartj/ehq368. Epub 2010 Oct 8. — View Citation

Fox K, Borer JS, Camm AJ, Danchin N, Ferrari R, Lopez Sendon JL, Steg PG, Tardif JC, Tavazzi L, Tendera M; Heart Rate Working Group. Resting heart rate in cardiovascular disease. J Am Coll Cardiol. 2007 Aug 28;50(9):823-30. Epub 2007 Aug 13. Review. — View Citation

Ho JE, Bittner V, Demicco DA, Breazna A, Deedwania PC, Waters DD. Usefulness of heart rate at rest as a predictor of mortality, hospitalization for heart failure, myocardial infarction, and stroke in patients with stable coronary heart disease (Data from the Treating to New Targets [TNT] trial). Am J Cardiol. 2010 Apr 1;105(7):905-11. doi: 10.1016/j.amjcard.2009.11.035. — View Citation

Kolloch R, Legler UF, Champion A, Cooper-Dehoff RM, Handberg E, Zhou Q, Pepine CJ. Impact of resting heart rate on outcomes in hypertensive patients with coronary artery disease: findings from the INternational VErapamil-SR/trandolapril STudy (INVEST). Eur Heart J. 2008 May;29(10):1327-34. doi: 10.1093/eurheartj/ehn123. Epub 2008 Mar 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with composite events including CVD mortality, fatal/non-fatal MI, non-fatal sudden cardiac arrest, fatal/non-fatal stroke and malignant arrhythmia		During PCI	No
Secondary	Mean perioperative clinical heart rate	The primary efficacy endpoint is proportion of patients with composite events including CVD mortality, fatal/non-fatal MI, non-fatal sudden cardiac arrest, fatal/non-fatal stroke and malignant arrhythmia.	During PCI	No
Secondary	Clinical resting heart rate and heart rate variability		During PCI	No