Myocardial InfarctionNCT00192790
Pain Perception is Attenuated in Patients With Painless Myocardial Infarction
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Myocardial Infarction, Myocardial Ischemia
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2004to Mar 2005
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:All patients with painless or painful myocardial infarction -
Exclusion Criteria:Patients who can't give informed concent or couldn't cooperate
-
Trial locations and contacts
1 site in 1 country.
Israel1 site
RAMBAM Health Care Campus, Internal Medicine "B" & Cardiology
Haifa, 31096
About this study
Official title: Clinical and Experimental Pain Perception is Attenuated in Patients With Painless Myocardial Infarction
To explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.
Read the detailed description
Objective: Silent myocardial infarction (MI) is an event of severe myocardial ischemia without pain experience. The lack of pain alarm leads to increased morbidity and mortality, because the patients do not sick timely medical treatment. This study aims to explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.
Methods: Level of chest pain intensity was assessed by visual analogue scale (VAS), range from 0 (no pain) to 100 (maximal pain). Heat pain threshold, magnitude estimation of supra-threshold painful stimuli at 47ºC as well as pain catastrophizing scores were assessed in 90 acute MI patients (mean age 66±12.1, range 33-79) with chest pain (n=65) and without pain symptoms(n=25). All stimuli were performed by Thermal Sensory Analysis (TSA) and applied to the right forearm.
Results: The demographic variables, history of ischemic heart, risk factors for coronary artery disease, ST-T segment changes on ECG and troponin levels were similar in both groups. Greater intensity of chest pain VAS scores was inversely correlated with lower pain threshold (r= -0.417, p<0.001), and directly associated with higher pain scores in response to the heat pain (r=0.354, p=0.002). Patients with painful MI demonstrated lower pain threshold (41.9±3.6 vs. 44.9±3.8, p=0.001), higher VAS scores in response to the supra-threshold painful stimuli (50.2 ±21.8 vs. 27.0±25.2, p=0.002), and higher catastrophizing level (10.6±12.0 vs. 5.4±8.8, p=0.032). Chest pain complaint was not related to ST-T changes as well as concomitant diseases.
Conclusions: This study suggests that reduced systemic pain perception as well as cognitive personality variables play an important role in the etiology of Silent MI.
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Keywords
- Therma,pain, Silent myocardial ischemia, catastrophizing
- Medical subject headings
- Myocardial Infarction, Myocardial Ischemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Investigators
- Zaher S. Azzam, MD, Principal investigator, Rambam Medical Center, The Ruth & Bruce Rappaport Faculty of Medicine Technion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192790
- Sponsor's protocol ID
- ZSA1871CTIL
- Status last verified
- Apr 2007
- First submitted
- 12 Sep 2005
- Last updated
- 11 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Granot M, Khoury R, Berger G, Krivoy N, Braun E, Aronson D, Azzam ZS. Clinical and experimental pain perception is attenuated in patients with painless myocardial infarction. Pain. 2007 Dec 15;133(1-3):120-7. doi: 10.1016/j.pain.2007.03.017. Epub 2007 Apr 25.
PubMed 17462825
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Experimental Pain Perception is Attenuated in Patients With Painless Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00192790
- Acronym / sponsor ID
- ZSA1871CTIL
- Conditions
- Myocardial Infarction, Myocardial Ischemia
- Keywords
- Therma,pain, Silent myocardial ischemia, catastrophizing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 19 Sep 2005 (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.
To explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.
Detailed description
Objective: Silent myocardial infarction (MI) is an event of severe myocardial ischemia without pain experience. The lack of pain alarm leads to increased morbidity and mortality, because the patients do not sick timely medical treatment. This study aims to explore whether reduced systemic pain perception in response to painful stimuli and personality pain related variables characterizes silent MI patients.
Methods: Level of chest pain intensity was assessed by visual analogue scale (VAS), range from 0 (no pain) to 100 (maximal pain). Heat pain threshold, magnitude estimation of supra-threshold painful stimuli at 47ºC as well as pain catastrophizing scores were assessed in 90 acute MI patients (mean age 66±12.1, range 33-79) with chest pain (n=65) and without pain symptoms(n=25). All stimuli were performed by Thermal Sensory Analysis (TSA) and applied to the right forearm.
Results: The demographic variables, history of ischemic heart, risk factors for coronary artery disease, ST-T segment changes on ECG and troponin levels were similar in both groups. Greater intensity of chest pain VAS scores was inversely correlated with lower pain threshold (r= -0.417, p<0.001), and directly associated with higher pain scores in response to the heat pain (r=0.354, p=0.002). Patients with painful MI demonstrated lower pain threshold (41.9±3.6 vs. 44.9±3.8, p=0.001), higher VAS scores in response to the supra-threshold painful stimuli (50.2 ±21.8 vs. 27.0±25.2, p=0.002), and higher catastrophizing level (10.6±12.0 vs. 5.4±8.8, p=0.032). Chest pain complaint was not related to ST-T changes as well as concomitant diseases.
Conclusions: This study suggests that reduced systemic pain perception as well as cognitive personality variables play an important role in the etiology of Silent MI.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 11 Apr 2007.
- Derived from this study: PubMed 17462825Granot M, Khoury R, Berger G, Krivoy N, Braun E, Aronson D, Azzam ZS. Clinical and experimental pain perception is attenuated in patients with painless myocardial infarction. Pain. 2007 Dec 15;133(1-3):120-7. doi: 10.1016/j.pain.2007.03.017. Epub 2007 Apr 25.
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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.
Zaher S. Azzam, MD principal investigator
Rambam Medical Center, The Ruth & Bruce Rappaport Faculty of Medicine Technion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Myocardial Ischemia, run by Rambam Health Care Campus 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?
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 11 Apr 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00192790, which also lists 1 linked publication.
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 11 Apr 2007.