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

• Conditions: Coronary Heart Disease

• Registration Number: NCT02351674
• Lead Sponsor: Dandan Li

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.

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-01-27
• Last Update Submitted: 2015-01-27
• Study First Posted: 2015-01-30
• Last Update Posted: 2015-01-30
• Primary Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Mean perioperative clinical heart rate	During PCI	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.
Clinical resting heart rate and heart rate variability	During PCI