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Clinical Trials/NCT02351674
NCT02351674
Unknown
Not Applicable

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

Dandan Li0 sites15,000 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Heart Disease
Sponsor
Dandan Li
Enrollment
15000
Primary Endpoint
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
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
September 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Dandan Li
Responsible Party
Sponsor Investigator
Principal Investigator

Dandan Li

M.D.

Chinese PLA General Hospital

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.

Outcomes

Primary Outcomes

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

Time Frame: During PCI

Secondary Outcomes

  • Mean perioperative clinical heart rate(During PCI)
  • Clinical resting heart rate and heart rate variability(During PCI)

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