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Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients (ACS QUIK)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Quality Improvement Toolkit
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presenting with Acute Coronary Syndrome

Exclusion Criteria:

  • Below the Age of 18
  • Patient without Acute Coronary Syndrome

Sites / Locations

  • Government Medical College Alappuzha
  • Samaritan Hospital
  • Little Flower Hospital & Research Center
  • Baby Memorial Hospital
  • Government Medical College Kozhikode
  • Metro International Cardiac Centre
  • Sree Narayana Institute of Medical Sciences
  • Rajah Charitable Medical Trust
  • KVM Hospital
  • PVS Memorial Hospital
  • Sukapuram Hospital
  • Irinjalakuda Co-operative Hospital Limited
  • Lal Memorial Hospital
  • Koyili Hospital
  • St. Martin De Porres Hospital
  • Pariyaram Medical College Hospital
  • Kannur Medical College Super Specialty Hospital
  • Lourdes Hospital
  • Lakshmi Hospital
  • Lisie Hospital
  • Indira Ghandi Co-operative Hospital
  • Amrita Institute of Medical Sciences & Research Center
  • Malankara Orthodox Syrian Church Medical College Hospital
  • AA Rahim Memorial District Hospital
  • Bishop Benziger Hospital
  • Dr. K. Damodaran Memoral Hospital
  • Holy Cross Hospital
  • Travancore Medical College
  • St. Joseph's Hospital
  • Malabar Institute of Medical Sciences
  • Bharath Cardiovascular Institute
  • S.H. Medical Centre Hospital
  • Government Medical College Kottayam
  • Caritas Hospital
  • KMCT Medical College
  • C.H. Memorial Hospital
  • Palakkad Government District Hospital
  • Thangam Hospital
  • Lakshmi Hospital
  • EMS Memorial Hospital
  • Ramdas Clinic & Nursing Home
  • Tellicherry Cooperative Hospital
  • SK Hospital
  • Medical College Thiruvananthapuram
  • Sree Chitra Institute for Medical Sciences and Technology
  • Ananthapuri Hospital and Research Institute
  • Noorul Islam Institute of Medical Science & Research Foundation
  • Sree Gokulam Medical College & Research Foundation
  • St. Mary's Hospital
  • Santhi Nursing Home
  • WestFort Hi-Tech Hospital Limited
  • Jubilee Mission Medical College & Research Institute
  • Elite Mission Hospital
  • Mother Hospital Limited
  • Aswini Hospital
  • Daya General Hospital & Specialty Surgery Centre
  • St. James Hospital
  • Amala Institute of Medical Sciences
  • Government Medical College Thrissur
  • Modern Hospital
  • Pushpagiri Institute of Medical Sciences and Research Centre
  • PRS Hospital
  • Kerala Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Step 1: Toolkit Implemented in Month 4

Step 2: Toolkit Implemented in Month 8

Step 3: Toolkit Implemented in Month 12

Step 4: Toolkit Implemented in Month 16

Step 5: Toolkit Implemented in Month 20

Arm Description

Quality Improvement Toolkit

Quality Improvement Toolkit

Quality Improvement Toolkit

Quality Improvement Toolkit

Quality Improvement Toolkit

Outcomes

Primary Outcome Measures

30-Day Major Adverse Cardiovascular Events
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on 30-day major adverse cardiovascular events (MACE [death, reinfarction stroke, or major bleeding]) in patients admitted with acute coronary syndrome, adjusted for hospital, time, and step.

Secondary Outcome Measures

In-Hospital Medication Rates
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital medication prescription rates.
Discharge Medication Rates
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.
Discharge Advice Relative to Healthy Lifestyles
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge advice relative to healthy lifestyles.
In-Hospital and 30-Day Expanded MACE
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital and 30-day expanded MACE.
Concordance with locally-defined performance measures and in-hospital and 30-day MACE
To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.
Health Related Quality of Life
To evaluate health related quality of life in post-ACS patients (30-days) using a translated and validated version of the Seattle Angina Questionnaire (SAQ).
Impoverishing Effects of an ACS Event
To evaluate individual- and household-level impoverishing effects of an ACS event in the context of the recent implementation of a national government insurance program for families below the poverty line.

Full Information

First Posted
October 1, 2014
Last Updated
August 15, 2018
Sponsor
Northwestern University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02256657
Brief Title
Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients
Acronym
ACS QUIK
Official Title
Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Cluster Randomized, Stepped Wedge Multi-center Implementation of a Locally-Developed Quality Improvement Toolkit
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The trial assesses the effect on 30-day major adverse cardiovascular event (MACE) rate of using a quality improvement toolkit among hospitals in Kerala, India. The quality improvement toolkit includes standardized admission and discharge sets, clinical pathways and an audit and feedback program.
Detailed Description
This study is a cluster randomized, stepped wedge clinical trial assessing implementation and effect of a locally-developed quality improvement toolkit for patients with acute coronary syndrome (ACS) in Kerala, India. Hospitals will be randomized after stratification for size to one of five cohorts. After a four-month baseline period, the quality improvement toolkit will be implemented in all hospitals in cohort 1. Through a one-way crossover design, these hospitals will continue to use the quality improvement toolkit through the end of the trial for all acute coronary syndrome (ACS) patients. Cohorts 2 through 5 will implement the quality improvement toolkit at time points 8, 12, 16, and 20 months respectively, continuing the use of the toolkits from that time forward to the end of the study. The primary outcome is 30-day MACE rates, including death, reinfarction stroke, or major bleeding. Rates will be continuously collected and compared at one interim time point for safety and efficacy. Final analysis compares MACE rates before and after implementation of the quality improvement toolkits, accounting for cluster effects of hospital, cohort and time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Step 1: Toolkit Implemented in Month 4
Arm Type
Experimental
Arm Description
Quality Improvement Toolkit
Arm Title
Step 2: Toolkit Implemented in Month 8
Arm Type
Experimental
Arm Description
Quality Improvement Toolkit
Arm Title
Step 3: Toolkit Implemented in Month 12
Arm Type
Experimental
Arm Description
Quality Improvement Toolkit
Arm Title
Step 4: Toolkit Implemented in Month 16
Arm Type
Experimental
Arm Description
Quality Improvement Toolkit
Arm Title
Step 5: Toolkit Implemented in Month 20
Arm Type
Experimental
Arm Description
Quality Improvement Toolkit
Intervention Type
Behavioral
Intervention Name(s)
Quality Improvement Toolkit
Intervention Description
The quality improvement toolkit is comprised of standardized admission and discharge checklists, clinical pathways, an audit and feedback mechanism through electronic data capture, and a monthly report used in conjunction with root cause analysis meetings. Quality improvement toolkits are implemented by individual hospitals.
Primary Outcome Measure Information:
Title
30-Day Major Adverse Cardiovascular Events
Description
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on 30-day major adverse cardiovascular events (MACE [death, reinfarction stroke, or major bleeding]) in patients admitted with acute coronary syndrome, adjusted for hospital, time, and step.
Time Frame
30 Days from Hospital Discharge
Secondary Outcome Measure Information:
Title
In-Hospital Medication Rates
Description
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital medication prescription rates.
Time Frame
30 Days
Title
Discharge Medication Rates
Description
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge medication prescription rates.
Time Frame
30 Days
Title
Discharge Advice Relative to Healthy Lifestyles
Description
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on discharge advice relative to healthy lifestyles.
Time Frame
30 Days
Title
In-Hospital and 30-Day Expanded MACE
Description
Compared with usual care, to evaluate the effect of a locally-developed, evidence-based health care quality improvement toolkit on in-hospital and 30-day expanded MACE.
Time Frame
30 Days
Title
Concordance with locally-defined performance measures and in-hospital and 30-day MACE
Description
To evaluate the association between concordance with locally-defined performance measures for ACS care and in-hospital and 30-day MACE.
Time Frame
30 Days
Title
Health Related Quality of Life
Description
To evaluate health related quality of life in post-ACS patients (30-days) using a translated and validated version of the Seattle Angina Questionnaire (SAQ).
Time Frame
30 Days
Title
Impoverishing Effects of an ACS Event
Description
To evaluate individual- and household-level impoverishing effects of an ACS event in the context of the recent implementation of a national government insurance program for families below the poverty line.
Time Frame
30 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting with Acute Coronary Syndrome Exclusion Criteria: Below the Age of 18 Patient without Acute Coronary Syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Huffman, MD, MPH
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
PP Mohanan, MD, DM
Organizational Affiliation
WestFort Hi-Tech Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Doirairaj Prabhakaran, MD, DM
Organizational Affiliation
Centre for Chronic Disease Control
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Donald Lloyd-Jones, MD, ScM
Organizational Affiliation
Northwestern University
Official's Role
Study Chair
Facility Information:
Facility Name
Government Medical College Alappuzha
City
Alappuzha
State/Province
Kerala
ZIP/Postal Code
688005
Country
India
Facility Name
Samaritan Hospital
City
Aluva
State/Province
Kerala
ZIP/Postal Code
683562
Country
India
Facility Name
Little Flower Hospital & Research Center
City
Angamaly
State/Province
Kerala
ZIP/Postal Code
683572
Country
India
Facility Name
Baby Memorial Hospital
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673004
Country
India
Facility Name
Government Medical College Kozhikode
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673008
Country
India
Facility Name
Metro International Cardiac Centre
City
Calicut
State/Province
Kerala
ZIP/Postal Code
673014
Country
India
Facility Name
Sree Narayana Institute of Medical Sciences
City
Chalakka
State/Province
Kerala
ZIP/Postal Code
683594
Country
India
Facility Name
Rajah Charitable Medical Trust
City
Chavakkad
State/Province
Kerala
ZIP/Postal Code
680506
Country
India
Facility Name
KVM Hospital
City
Cherthala
State/Province
Kerala
ZIP/Postal Code
688524
Country
India
Facility Name
PVS Memorial Hospital
City
Cochin
State/Province
Kerala
ZIP/Postal Code
682017
Country
India
Facility Name
Sukapuram Hospital
City
Edapal
State/Province
Kerala
ZIP/Postal Code
679576
Country
India
Facility Name
Irinjalakuda Co-operative Hospital Limited
City
Irinjalakuda
State/Province
Kerala
ZIP/Postal Code
680661
Country
India
Facility Name
Lal Memorial Hospital
City
Irinjalakuda
State/Province
Kerala
ZIP/Postal Code
680712
Country
India
Facility Name
Koyili Hospital
City
Kannur
State/Province
Kerala
ZIP/Postal Code
670004
Country
India
Facility Name
St. Martin De Porres Hospital
City
Kannur
State/Province
Kerala
ZIP/Postal Code
670301
Country
India
Facility Name
Pariyaram Medical College Hospital
City
Kannur
State/Province
Kerala
ZIP/Postal Code
670503
Country
India
Facility Name
Kannur Medical College Super Specialty Hospital
City
Kannur
State/Province
Kerala
ZIP/Postal Code
670612
Country
India
Facility Name
Lourdes Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682012
Country
India
Facility Name
Lakshmi Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682016
Country
India
Facility Name
Lisie Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682018
Country
India
Facility Name
Indira Ghandi Co-operative Hospital
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682020
Country
India
Facility Name
Amrita Institute of Medical Sciences & Research Center
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Malankara Orthodox Syrian Church Medical College Hospital
City
Kolenchery
State/Province
Kerala
ZIP/Postal Code
682311
Country
India
Facility Name
AA Rahim Memorial District Hospital
City
Kollam
State/Province
Kerala
ZIP/Postal Code
691001
Country
India
Facility Name
Bishop Benziger Hospital
City
Kollam
State/Province
Kerala
ZIP/Postal Code
691001
Country
India
Facility Name
Dr. K. Damodaran Memoral Hospital
City
Kollam
State/Province
Kerala
ZIP/Postal Code
691001
Country
India
Facility Name
Holy Cross Hospital
City
Kollam
State/Province
Kerala
ZIP/Postal Code
691571
Country
India
Facility Name
Travancore Medical College
City
Kollam
State/Province
Kerala
ZIP/Postal Code
691589
Country
India
Facility Name
St. Joseph's Hospital
City
Kothamangalam
State/Province
Kerala
ZIP/Postal Code
686691
Country
India
Facility Name
Malabar Institute of Medical Sciences
City
Kottakkal
State/Province
Kerala
ZIP/Postal Code
676503
Country
India
Facility Name
Bharath Cardiovascular Institute
City
Kottayam
State/Province
Kerala
ZIP/Postal Code
686001
Country
India
Facility Name
S.H. Medical Centre Hospital
City
Kottayam
State/Province
Kerala
ZIP/Postal Code
686001
Country
India
Facility Name
Government Medical College Kottayam
City
Kottayam
State/Province
Kerala
ZIP/Postal Code
686008
Country
India
Facility Name
Caritas Hospital
City
Kottayam
State/Province
Kerala
ZIP/Postal Code
686630
Country
India
Facility Name
KMCT Medical College
City
Kozhikode
State/Province
Kerala
ZIP/Postal Code
673602
Country
India
Facility Name
C.H. Memorial Hospital
City
Malappuram
State/Province
Kerala
ZIP/Postal Code
676552
Country
India
Facility Name
Palakkad Government District Hospital
City
Palakkad
State/Province
Kerala
ZIP/Postal Code
678001
Country
India
Facility Name
Thangam Hospital
City
Palakkad
State/Province
Kerala
ZIP/Postal Code
678004
Country
India
Facility Name
Lakshmi Hospital
City
Palakkad
State/Province
Kerala
ZIP/Postal Code
678013
Country
India
Facility Name
EMS Memorial Hospital
City
Perintalmanna
State/Province
Kerala
ZIP/Postal Code
679322
Country
India
Facility Name
Ramdas Clinic & Nursing Home
City
Perintalmanna
State/Province
Kerala
ZIP/Postal Code
679322
Country
India
Facility Name
Tellicherry Cooperative Hospital
City
Thalassery
State/Province
Kerala
ZIP/Postal Code
670101
Country
India
Facility Name
SK Hospital
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695006
Country
India
Facility Name
Medical College Thiruvananthapuram
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Sree Chitra Institute for Medical Sciences and Technology
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695011
Country
India
Facility Name
Ananthapuri Hospital and Research Institute
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695024
Country
India
Facility Name
Noorul Islam Institute of Medical Science & Research Foundation
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695123
Country
India
Facility Name
Sree Gokulam Medical College & Research Foundation
City
Thiruvananthapuram
State/Province
Kerala
ZIP/Postal Code
695607
Country
India
Facility Name
St. Mary's Hospital
City
Thodupuzha
State/Province
Kerala
ZIP/Postal Code
685584
Country
India
Facility Name
Santhi Nursing Home
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
679561
Country
India
Facility Name
WestFort Hi-Tech Hospital Limited
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680002
Country
India
Facility Name
Jubilee Mission Medical College & Research Institute
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680005
Country
India
Facility Name
Elite Mission Hospital
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680007
Country
India
Facility Name
Mother Hospital Limited
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680012
Country
India
Facility Name
Aswini Hospital
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680020
Country
India
Facility Name
Daya General Hospital & Specialty Surgery Centre
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680022
Country
India
Facility Name
St. James Hospital
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680307
Country
India
Facility Name
Amala Institute of Medical Sciences
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680555
Country
India
Facility Name
Government Medical College Thrissur
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680596
Country
India
Facility Name
Modern Hospital
City
Thrissur
State/Province
Kerala
ZIP/Postal Code
680664
Country
India
Facility Name
Pushpagiri Institute of Medical Sciences and Research Centre
City
Tiruvalla
State/Province
Kerala
ZIP/Postal Code
689101
Country
India
Facility Name
PRS Hospital
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695002
Country
India
Facility Name
Kerala Institute of Medical Sciences
City
Trivandrum
State/Province
Kerala
ZIP/Postal Code
695029
Country
India

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual patient data for ACS QUIK will be shared through NHBLI BIOLINCC.
IPD Sharing Time Frame
Data have been distributed to NHLBI BIOLINCC.
IPD Sharing Access Criteria
Access to data will be managed through NLHBI BIOLINCC request process.
Citations:
PubMed Identifier
28267469
Citation
Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Lloyd-Jones DM, Prabhakaran D. Acute coronary syndrome quality improvement in Kerala (ACS QUIK): Rationale and design for a cluster-randomized stepped-wedge trial. Am Heart J. 2017 Mar;185:154-160. doi: 10.1016/j.ahj.2016.10.026. Epub 2016 Dec 21.
Results Reference
background
PubMed Identifier
29450524
Citation
Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Krishnan MN, Natesan S, Gopinath R, Viswanathan S, Stigi J, Joseph J, Chozhakkat S, Lloyd-Jones DM, Prabhakaran D; Acute Coronary Syndrome Quality Improvement in Kerala (ACS QUIK) Investigators. Effect of a Quality Improvement Intervention on Clinical Outcomes in Patients in India With Acute Myocardial Infarction: The ACS QUIK Randomized Clinical Trial. JAMA. 2018 Feb 13;319(6):567-578. doi: 10.1001/jama.2017.21906.
Results Reference
result
PubMed Identifier
32559257
Citation
Pei J, Wang X, Xing Z, Chen P, Su W, Deng S, Hu X. Association between admission systolic blood pressure and major adverse cardiovascular events in patients with acute myocardial infarction. PLoS One. 2020 Jun 19;15(6):e0234935. doi: 10.1371/journal.pone.0234935. eCollection 2020.
Results Reference
derived
PubMed Identifier
30755027
Citation
Huffman MD, Mohanan PP, Devarajan R, Baldridge AS, Kondal D, Zhao L, Ali M, Spertus JA, Chan PS, Natesan S, Abdullakutty J, Krishnan MN, Tp A, Renga S, Punnoose E, Unni G, Prabhakaran D, Lloyd-Jones DM; ACS QUIK Investigators. Health-Related Quality of Life at 30 Days Among Indian Patients With Acute Myocardial Infarction. Circ Cardiovasc Qual Outcomes. 2019 Feb;12(2):e004980. doi: 10.1161/CIRCOUTCOMES.118.004980.
Results Reference
derived
PubMed Identifier
30728053
Citation
Singh K, Devarajan R, Mohanan PP, Baldridge AS, Kondal D, Victorson DE, Karmali KN, Zhao L, Lloyd-Jones DM, Prabhakaran D, Goenka S, Huffman MD; ACS QUIK Investigators. Implementation and acceptability of a heart attack quality improvement intervention in India: a mixed methods analysis of the ACS QUIK trial. Implement Sci. 2019 Feb 6;14(1):12. doi: 10.1186/s13012-019-0857-7.
Results Reference
derived
PubMed Identifier
29150536
Citation
Sarma S, Harikrishnan S, Baldridge AS, Devarajan R, Mehta A, Selvaraj S, Ali MK, Mohanan PP, Prabhakaran D, Huffman MD. Availability, Sales, and Affordability of Tobacco Cessation Medicines in Kerala, India. Circ Cardiovasc Qual Outcomes. 2017 Nov;10(11):e004108. doi: 10.1161/CIRCOUTCOMES.117.004108.
Results Reference
derived

Learn more about this trial

Study of a Quality Improvement Toolkit in Kerala, India, Among Hospitals Treating Acute Coronary Syndrome Patients

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