HealthyNCT00001528
Analysis of Heart Muscle Function Following Exercise in Patients With Heart Disease
An observational study of Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study is designed to examine the blood flow, the nutrition, and the beating function of the heart under different conditions. Patients with narrowed coronary arteries my have restricted blood flow to the heart. The lowered blood supply to the heart muscle may not cause symptoms immediately. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1996to Mar 2001
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Adult patients with greater than 50% stenosis in at least one major coronary artery.
No significant valvular heart disease.
No congenital heart disease.
No myocardial disease unrelated to co-existing coronary artery disease.
No severe angina where withdrawal of therapy would be dangerous.
No recent unstable angina or myocardial infarction (less than 1 month).
Not pregnant or breast feeding.
No history of ventricular tachycardia or malignant arrhythmias.
No history of active bronchospastic disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Post-Stress Left Ventricular Contractile Dysfunction: Does It Represent Persistent Myocardial Ischemia or Stunning?
This study is designed to examine the blood flow, the nutrition, and the beating function of the heart under different conditions. Patients with narrowed coronary arteries my have restricted blood flow to the heart. The lowered blood supply to the heart muscle may not cause symptoms immediately. However, as the heart pumps faster and harder the blood supply demand is increased. If blood flow is unable supply enough oxygen and nutrition to heart muscle patients can experience symptoms of chest pain and shortness of breath. Even after the heart slows down and demand for oxygen and nutrition is reduced, patients can still experience pain and abnormal heart function.
The purpose of this study is to determine the changes in blood flow and the beating function of the heart during periods of increased demands (such as exercise) and shortly after stopping exercise.
Read more
Blood flow to the heart will be measured by positron emission tomography (PET scan). The PET scan is a test where a small amount of radioactive water is injected into the bloodstream and pictures of the heart are taken by the special camera. This procedure allows researchers to measure blood flow to heart muscle. In order to measure nutrition (metabolism) of the heart muscle, researchers will use a radioactive substance similar to sugar (Fluorodeoxyglucose).
Results of this study may provide important information about the activity and function of heart muscle after exercise in patients suffering from coronary artery disease.
Read the detailed description
Exercise-induced left ventricular regional wall motion abnormalities among patients with coronary artery disease indicate myocardial ischemia due to significant coronary artery narrowing. Recovery of such stress-induced wall motion abnormalities is thought to occur within minutes after the termination of exercise. However, in some patients, persistent contractile dysfunction has been observed up to 90 minutes into recovery. Whether persistent regional wall motion abnormalities after exercise are due to stunned myocardium (prolonged but reversible postischemic dysfunction despite restoration of blood flow) or persistent ischemia due to coronary vasoconstriction (prolonged postischemic dysfunction due to persistent reduction of regional blood flow) is not well established. It is possible that persistent but reversible left ventricular dysfunction post-exercise may represent persistent reduction in regional blood flow and/or altered regional metabolic state.
In this protocol, we intend to elucidate the mechanisms of prolonged but reversible post-exercise left ventricular contractile dysfunction. Results of this study may provide insight into the post-exercise cardiovascular physiology among patients with coronary artery disease. In addition, clinical implications can be drawn regarding patient safety and timing of discharge from the exercise laboratory, as well as timing of post-exercise myocardial perfusion studies.
We propose to evaluate left ventricular regional wall motion by gated blood pool tomographic (SPECT) imaging at rest, during maximal exercise, 15 and 30 minutes after termination of exercise. Myocardial perfusion (O-15 water) and metabolic (F-18 deoxyglucose) studies will be performed utilizing positron emission tomography (PET). Absolute regional myocardial blood flow (ml/min/gm) will be assessed at rest, during maximal exercise, 15 and 30 minutes post-exercise along with myocardial fluorodeoxyglucose utilization 45 to 90 minutes post-exercise. Patients afflicted with conditions that limit their capacity to perform an adequate exercise study will undergo pharmacological stress study with dobutamine. Normal subjects will also be studied in order to create a control database.
- Conditions
- Healthy
- Keywords
- Coronary Artery Disease, Gated Blood Pool Tomography, Myocardial Blood Flow, Myocardial Stunning, Positron Emission Tomography
- Medical subject headings
- Coronary Artery Disease, Myocardial Stunning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startFeb 1996
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Enrolment
- 80 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001528
- Sponsor's protocol ID
- 960031
- Other IDs
- 96-H-0031
- Status last verified
- Apr 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kloner RA, Allen J, Cox TA, Zheng Y, Ruiz CE. Stunned left ventricular myocardium after exercise treadmill testing in coronary artery disease. Am J Cardiol. 1991 Aug 1;68(4):329-34. doi: 10.1016/0002-9149(91)90827-8.
PubMed 1858675Camici P, Araujo LI, Spinks T, Lammertsma AA, Kaski JC, Shea MJ, Selwyn AP, Jones T, Maseri A. Increased uptake of 18F-fluorodeoxyglucose in postischemic myocardium of patients with exercise-induced angina. Circulation. 1986 Jul;74(1):81-8. doi: 10.1161/01.cir.74.1.81.
PubMed 3486725
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Stress Left Ventricular Contractile Dysfunction: Does It Represent Persistent Myocardial Ischemia or Stunning?
- ClinicalTrials.gov ID
- NCT00001528
- Acronym / sponsor ID
- 960031
- Conditions
- Healthy
- Keywords
- Coronary Artery Disease, Gated Blood Pool Tomography, Myocardial Blood Flow, Myocardial Stunning, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Feb 1996
- Study completion
- Mar 2001
- First posted
- 10 Dec 2002 (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.
This study is designed to examine the blood flow, the nutrition, and the beating function of the heart under different conditions. Patients with narrowed coronary arteries my have restricted blood flow to the heart. The lowered blood supply to the heart muscle may not cause symptoms immediately. However, as the heart pumps faster and harder the blood supply demand is increased. If blood flow is unable supply enough oxygen and nutrition to heart muscle patients can experience symptoms of chest pain and shortness of breath. Even after the heart slows down and demand for oxygen and nutrition is reduced, patients can still experience pain and abnormal heart function.
The purpose of this study is to determine the changes in blood flow and the beating function of the heart during periods of increased demands (such as exercise) and shortly after stopping exercise.
Blood flow to the heart will be measured by positron emission tomography (PET scan). The PET scan is a test where a small amount of radioactive water is injected into the bloodstream and pictures of the heart are taken by the special camera. This procedure allows researchers to measure blood flow to heart muscle. In order to measure nutrition (metabolism) of the heart muscle, researchers will use a radioactive substance similar to sugar (Fluorodeoxyglucose).
Results of this study may provide important information about the activity and function of heart muscle after exercise in patients suffering from coronary artery disease.
Detailed description
Exercise-induced left ventricular regional wall motion abnormalities among patients with coronary artery disease indicate myocardial ischemia due to significant coronary artery narrowing. Recovery of such stress-induced wall motion abnormalities is thought to occur within minutes after the termination of exercise. However, in some patients, persistent contractile dysfunction has been observed up to 90 minutes into recovery. Whether persistent regional wall motion abnormalities after exercise are due to stunned myocardium (prolonged but reversible postischemic dysfunction despite restoration of blood flow) or persistent ischemia due to coronary vasoconstriction (prolonged postischemic dysfunction due to persistent reduction of regional blood flow) is not well established. It is possible that persistent but reversible left ventricular dysfunction post-exercise may represent persistent reduction in regional blood flow and/or altered regional metabolic state.
In this protocol, we intend to elucidate the mechanisms of prolonged but reversible post-exercise left ventricular contractile dysfunction. Results of this study may provide insight into the post-exercise cardiovascular physiology among patients with coronary artery disease. In addition, clinical implications can be drawn regarding patient safety and timing of discharge from the exercise laboratory, as well as timing of post-exercise myocardial perfusion studies.
We propose to evaluate left ventricular regional wall motion by gated blood pool tomographic (SPECT) imaging at rest, during maximal exercise, 15 and 30 minutes after termination of exercise. Myocardial perfusion (O-15 water) and metabolic (F-18 deoxyglucose) studies will be performed utilizing positron emission tomography (PET). Absolute regional myocardial blood flow (ml/min/gm) will be assessed at rest, during maximal exercise, 15 and 30 minutes post-exercise along with myocardial fluorodeoxyglucose utilization 45 to 90 minutes post-exercise. Patients afflicted with conditions that limit their capacity to perform an adequate exercise study will undergo pharmacological stress study with dobutamine. Normal subjects will also be studied in order to create a control database.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 4 Mar 2008.
- Background: PubMed 1858675Kloner RA, Allen J, Cox TA, Zheng Y, Ruiz CE. Stunned left ventricular myocardium after exercise treadmill testing in coronary artery disease. Am J Cardiol. 1991 Aug 1;68(4):329-34. doi: 10.1016/0002-9149(91)90827-8.
- Background: PubMed 3486725Camici P, Araujo LI, Spinks T, Lammertsma AA, Kaski JC, Shea MJ, Selwyn AP, Jones T, Maseri A. Increased uptake of 18F-fluorodeoxyglucose in postischemic myocardium of patients with exercise-induced angina. Circulation. 1986 Jul;74(1):81-8. doi: 10.1161/01.cir.74.1.81.
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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?
An observational study of Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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 NCT00001528, which also lists 2 linked publications.
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 4 Mar 2008.