Use of Atropine in Tredmill Stress Testing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mohamed Jabaren, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00623207
First received: February 14, 2008
Last updated: July 24, 2015
Last verified: July 2015
  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:


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 ]

Enrollment: 103
Study Start Date: December 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623207

Locations
Israel
Heart Institute, Ha'Emek Medical Center
Afula, Israel, 18100
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

No publications provided

Responsible Party: Mohamed Jabaren, MD, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT00623207     History of Changes
Other Study ID Numbers: 07-0139 EMC
Study First Received: February 14, 2008
Last Updated: July 24, 2015
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
Anti-Arrhythmia Agents
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Mydriatics
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015