Use of Atropine in Tredmill Stress Testing

July 24, 2015 updated by: Mohamed Jabaren, HaEmek Medical Center, Israel

Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18100
        • Heart Institute, Ha'Emek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 yaer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 22, 2008

First Posted (Estimate)

February 25, 2008

Study Record Updates

Last Update Posted (Estimate)

July 27, 2015

Last Update Submitted That Met QC Criteria

July 24, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-0139 EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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