NCT02351674

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

8 months

First QC Date

January 27, 2015

Last Update Submit

January 27, 2015

Conditions

Coronary Heart Disease

Keywords

Heart RatePercutaneous coronary interventionoutcome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mean perioperative clinical heart rate

    During PCI

  • Clinical resting heart rate and heart rate variability

    During PCI

Study Arms (4)

Heart rate ≤70bpm

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 1 will be defined as subjects' mean heart rate ≤70 BPM.

Heart rate between 71 to 80bpm

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 2 will be defined as subjects' mean heart rate between 71 to 80bpm.

Heart rate between 81 to 90bpm

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 1 will be defined as subjects' mean heart rate between 81 to 90bpm.

Heart rate>90bpm

15,000 patients in the retrospective cohort will be divided into 4 groups according to their mean heart rate during PCI. Group 4 will be defined as subjects' mean heart rate\>90bpm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 17719466BACKGROUND

  • 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.

    PMID: 20346304BACKGROUND

  • 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.

    PMID: 18375982BACKGROUND

  • 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.

    PMID: 20935002BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Yundai Chen, Ph.D.

    Ph.D. advisor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dandan Li, M.D.

CONTACT

+86 10 55499135ldd301heart@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

January 1, 2015

Primary Completion

September 1, 2015

Last Updated

January 30, 2015

Record last verified: 2015-01