Chest PainPhase 3NCT00623207
Use of Atropine in Tredmill Stress Testing
A Phase 3 study testing Atropine in people with Chest Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chest Pain
- What is being tested?
- Atropine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to Oct 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chest pain without evidence of ischemia eligible for exercise test.
- Age> 18 years old
Who cannot join
- Absolute:
- Patients with LBBB
- Unstable Angina
- Recent Myocardial Infarction
- Un controlled Arrythmia
- Congestive heart faliure
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chest Pain
- Being tested
- Atropine
- Keywords
- Chest Pain Low work Capacity Rate Incompetence
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
I.V Atropine 0.5mg up to 2 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Pateints who achieve target haert rate or conclusive test will not be given Atropine Receives: Drug: Atropine |
| 2 | Active comparator | Patients who won't achieve tarhet heart rate or conclusive results will be given Atropine Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 yaer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Jabaren, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623207
- Sponsor's protocol ID
- 07-0139 EMC
- Status last verified
- Jul 2015
- First submitted
- 14 Feb 2008
- Last updated
- 27 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.
- ClinicalTrials.gov ID
- NCT00623207
- Acronym / sponsor ID
- 07-0139 EMC
- Conditions
- Chest Pain
- Keywords
- Chest Pain Low work Capacity Rate Incompetence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: AtropinePateints who achieve target haert rate or conclusive test will not be given Atropine |
| 2 | Active comparator | Drug: AtropinePatients who won't achieve tarhet heart rate or conclusive results will be given Atropine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chest pain without evidence of ischemia eligible for exercise test.
- Age> 18 years old
Key exclusion criteria (17 listed)
- Patients with LBBB
- Unstable Angina
- Recent Myocardial Infarction
- Un controlled Arrythmia
- Congestive heart faliure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtropineI.V Atropine 0.5mg up to 2 mg | Drug | 1, 2 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atropine in people with Chest Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2015; AzTrials last refreshed its copy on 6 Nov 2026.