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Use of Atropine in Tredmill Stress Testing

Primary Purpose

Chest Pain

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Atropine
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain focused on measuring Chest Pain Low work Capacity Rate Incompetence

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with chest pain without evidence of ischemia eligible for exercise test.
  • Age> 18 years old

Exclusion Criteria:

Absolute:

  • Patients with LBBB
  • Unstable Angina
  • Recent Myocardial Infarction
  • Un controlled Arrythmia
  • Congestive heart faliure
  • Severe symptomatic valvular heart disease
  • Acute Pulmonary Embolism
  • Acute perimyocarditis
  • Acute aortic dissection

Relative:

  • Lt main stenosis
  • Severe hypertention (Systolic> 200 mmHg; Diastolic > 100 mmHg)
  • Cardiomyopathy
  • Obstructiove abnormalities
  • Psychiatric disorders
  • High degree AV Block

Sites / Locations

  • Heart Institute, Ha'Emek Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

1

2

Arm Description

Pateints who achieve target haert rate or conclusive test will not be given Atropine

Patients who won't achieve tarhet heart rate or conclusive results will be given Atropine

Outcomes

Primary Outcome Measures

1- To characterize patients who can't achieve target heart rate at treadmill exercise test.2- To evaluate atropine added during treadmill stress testing in order to increase heart rate and achieave conclusive test.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2008
Last Updated
July 24, 2015
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT00623207
Brief Title
Use of Atropine in Tredmill Stress Testing
Official Title
Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the Safety and feasibility of atropine added during treadmill stress testing in patients with chronotropic incompetence or poor exercise capacity. Our hypothesis is that we can increase heart rate by using atropin in these patients, so we will achieve more conclusive results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain
Keywords
Chest Pain Low work Capacity Rate Incompetence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Pateints who achieve target haert rate or conclusive test will not be given Atropine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients who won't achieve tarhet heart rate or conclusive results will be given Atropine
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
I.V Atropine 0.5mg up to 2 mg
Primary Outcome Measure Information:
Title
1- To characterize patients who can't achieve target heart rate at treadmill exercise test.2- To evaluate atropine added during treadmill stress testing in order to increase heart rate and achieave conclusive test.
Time Frame
1 yaer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with chest pain without evidence of ischemia eligible for exercise test. Age> 18 years old Exclusion Criteria: Absolute: Patients with LBBB Unstable Angina Recent Myocardial Infarction Un controlled Arrythmia Congestive heart faliure Severe symptomatic valvular heart disease Acute Pulmonary Embolism Acute perimyocarditis Acute aortic dissection Relative: Lt main stenosis Severe hypertention (Systolic> 200 mmHg; Diastolic > 100 mmHg) Cardiomyopathy Obstructiove abnormalities Psychiatric disorders High degree AV Block
Facility Information:
Facility Name
Heart Institute, Ha'Emek Medical Center
City
Afula
ZIP/Postal Code
18100
Country
Israel

12. IPD Sharing Statement

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Use of Atropine in Tredmill Stress Testing

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