Clinical trial NCT02351674: Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI
Official title: A Single Centre, Retrospective Cohort Study on Post Analysis on the Link Between the Clinical Heart Rate and Outcomes During PCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Keywords: Heart Rate
Percutaneous coronary intervention
outcome
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-01-30
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: During PCI
Secondary outcomes:
measure: Mean perioperative clinical heart rate
timeFrame: During PCI
measure: Clinical resting heart rate and heart rate variability
timeFrame: During PCI
Other outcomes:
Locations:
Study officials:
affiliation: Ph.D. advisor
name: Yundai Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.jacc.2007.04.079. Epub 2007 Aug 13.
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.
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.
citation: Anselmino M, Ohrvik J, Ryden 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.