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Use of Atropine in Tredmill Stress Testing

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ClinicalTrials.gov Identifier: NCT00623207
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):
Mohamed Jabaren, HaEmek Medical Center, Israel

Study Description
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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.


Condition or disease Intervention/treatment Phase
Chest Pain Drug: Atropine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.
Study Start Date : December 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Pateints who achieve target haert rate or conclusive test will not be given Atropine
 Drug: Atropine
I.V Atropine 0.5mg up to 2 mg
Active Comparator: 2
Patients who won't achieve tarhet heart rate or conclusive results will be given Atropine
 Drug: Atropine
I.V Atropine 0.5mg up to 2 mg


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623207


Locations
Israel
Heart Institute, Ha'Emek Medical Center
Afula, Israel, 18100
Sponsors and Collaborators
HaEmek Medical Center, Israel
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mohamed Jabaren, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00623207     History of Changes
Other Study ID Numbers: 07-0139 EMC
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

Keywords provided by Mohamed Jabaren, HaEmek Medical Center, Israel:
Chest Pain Low work Capacity Rate Incompetence

Additional relevant MeSH terms:
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Atropine
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action