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Use of Atropine in Tredmill Stress Testing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00623207
First received: February 14, 2008
Last updated: February 22, 2008
Last verified: February 2008
History of Changes
  Purpose

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 Intervention Phase
Chest Pain
 Drug: Atropine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

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. [ Time Frame: 1 yaer ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: December 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00623207

Contacts
Contact: Mohamed Jabaren, MD 972-4-6495273 jabaren_mo@clalit.org.il
Contact: Yoav Turgeman, MD 972- 4- 6494144 yoav_t@clalit.org.il

Locations
Israel
Heart Institute, Ha'Emek Medical Center Recruiting
Afula, Israel, 18100
Contact: Mohamed Jabaren, MD     972- 4- 6495273     jabaren_mo@clalit.org.il    
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Dr. Mohamed Jabaren, Ha'Emeh Medical Center, Afula
ClinicalTrials.gov Identifier: NCT00623207     History of Changes
Other Study ID Numbers: 07-0139 EMC
Study First Received: February 14, 2008
Last Updated: February 22, 2008
Health Authority: Israel: Ethics Commission

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

Additional relevant MeSH terms:
Chest Pain
Pain
Signs and Symptoms
Atropine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular 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

ClinicalTrials.gov processed this record on May 22, 2013