Cardiovascular DiseasesNCT00119847
Electrophysiological Effects of Late PCI After MI
A study testing PCI and Optimal Medical Therapy in people with Cardiovascular Diseases and Heart Diseases, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction
- What is being tested?
- PCI and Optimal Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Dec 2006
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has experienced a heart attack 3 to 28 days prior to study entry
- Persistently occluded IRA defined as either: 1) Thrombolysis in Myocardial Infarction (TIMI) 0, with no flow beyond the site of occlusion; or 2) TIMI 1, with penetration of dye beyond the site of occlusion without dye reaching the distal vessel
- LVEF less than 50% or proximal occlusion in a large vessel
- Normal sinus rhythm
- QRS duration less than 120 ms
- Able to return for follow-up assessment of arrhythmia markers one month and one year after study entry
Who cannot join
- Has a clinical indication for revascularization (post-heart attack angina at rest; significant inducible ischemia; or significant left main or triple vessel disease requiring PTCA or CABG)
- Current serious illness or condition that limits 3-year survival
- Severe valvular disease
- Chronic total occlusion
- New York Heart Association Class III-IV congestive heart failure
- Prior left ventricular aneurysm in the recent heart attack location
Show all 9Show fewer
- Is a poor candidate for PTCA/stent on the basis of angiographic or clinical criteria
- Cannot medically survive anticoagulation during PTCA/stent or antiplatelet therapy after stent
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
Official title: Electrophysiological Effects of Late PCI (OAT-EP)
The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.
Read the detailed description
BACKGROUND:
There is now unequivocal evidence that early coronary reperfusion using either thrombolytics or primary angioplasty results in a long-term mortality reduction among individuals who have had a heart attack. The benefit of early reperfusion (less than 6 hours after the heart attack) was initially attributed to myocardial salvage and the resultant preservation of left ventricular function. However, it is now known that the survival benefit associated with thrombolytic therapy is not consistently associated with a major improvement in left ventricular ejection fraction (LVEF). These observations led to the formulation of the "late open artery hypothesis," which suggests that clinical outcomes can potentially be improved by late reperfusion after a heart attack. Observational clinical studies have suggested that late patency of the infarct-related artery (IRA) after thrombolysis is associated with a survival benefit that is independent of LVEF and therefore cannot be solely explained by salvage of myocardium. Definitive proof of the late open artery hypothesis is currently lacking, however, because previous studies that have evaluated late percutaneous transluminal coronary angioplasty (PTCA) of occluded IRAs after a heart attack have produced conflicting results.
These findings led to the organization of the Occluded Artery Trial (OAT), an international, NHLBI-funded, randomized trial of 2,200 participants. OAT is testing the hypothesis that mechanical reperfusion of an occluded IRA with PTCA and percutaneous coronary intervention (PCI) 3 to 28 days after a heart attack in high-risk individuals will reduce mortality, recurrent heart attacks, and hospitalization for class IV congestive heart failure. Enhancement of electrical stability is one of the major mechanisms that has been proposed to explain the association of an open IRA with an improved prognosis independent of myocardial salvage.
DESIGN NARRATIVE:
This study is an ancillary study of OAT. It will characterize the effects of late PCI of occluded IRAs on the most important and clinically relevant noninvasive markers of vulnerability to malignant ventricular arrhythmias: heart rate variability, T wave variability, and signal-averaged electrocardiography. These analyses will be performed in 300 participants at baseline, 30 days, and 1 year following a heart attack in order to determine the effects of late PCI on the autonomic nervous system, ventricular repolarization, and ventricular conduction abnormalities.
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Coronary Disease, Arrhythmia, Ventricular Fibrillation
- Being tested
- PCI, Optimal Medical Therapy
- Keywords
- Stents, myocardial infarction
- Medical subject headings
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Coronary Disease, Arrhythmias, Cardiac, Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
Also called Angioplasty and stenting of the infarct-related artery
Optimal Medical TherapyDrug
Guideline-directed drug therapies after MI
| Study group | Role | What they receive |
|---|---|---|
| PCI+MED | Experimental | Percutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy Receives: Procedure: PCI; Drug: Optimal Medical Therapy |
| MED | Experimental | Optimal medical therapy alone Receives: Drug: Optimal Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-termed Fractal Scaling Exponent (Alpha 1)
Nonlinear measurement of heart rate variability, change between baseline and 1 year is the primary outcome.
Measured: Baseline, one year
Secondary outcomes (2)
T-wave Variability
Variability in T wave morphology, change between baseline and one year
Measured: Baseline and one year
Filtered QRS Duration
Signal-averaged ECG
Measured: Baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startSep 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Eric Rashba, University of Maryland, Baltimore
- Investigators
- Eric J. Rashba, MD, Study chair, Stony Brook University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119847
- Sponsor's protocol ID
- 221
- Other IDs
- R01HL072906
- Status last verified
- May 2022
- First submitted
- 6 Jul 2005
- Last updated
- 18 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rashba EJ. Assessment of ventricular repolarization abnormalities in congenital long QT syndrome. J Cardiovasc Electrophysiol. 2004 May;15(5):557-9. doi: 10.1046/j.1540-8167.2004.04022.x. No abstract available.
PubMed 15149425Rashba EJ. Should T-wave alternans testing be used to risk stratify candidates for prophylactic implantable cardioverter-defibrillator therapy? Heart Rhythm. 2005 Mar;2(3):242-4. doi: 10.1016/j.hrthm.2004.12.015. No abstract available.
PubMed 15851311Rashba EJ, Lamas GA, Couderc JP, Hollist SM, Dzavik V, Ruzyllo W, Fridrich V, Buller CE, Forman SA, Kufera JA, Carvalho AC, Hochman JS; OAT-EP Investigators. Electrophysiological effects of late percutaneous coronary intervention for infarct-related coronary artery occlusion: the Occluded Artery Trial-Electrophysiological Mechanisms (OAT-EP). Circulation. 2009 Feb 17;119(6):779-87. doi: 10.1161/CIRCULATIONAHA.108.808626. Epub 2009 Feb 2.
PubMed 19188505
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Effects of Late PCI (OAT-EP)
- ClinicalTrials.gov ID
- NCT00119847
- Acronym / sponsor ID
- 221
- Conditions
- Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Coronary Disease, Arrhythmia, Ventricular Fibrillation
- Keywords
- Stents, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Sep 2002 (actual)
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Posted 23 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if opening blocked arteries with heart balloons and stents prevents heart rhythm problems in individuals 3 to 28 days after a heart attack.
Detailed description
BACKGROUND:
There is now unequivocal evidence that early coronary reperfusion using either thrombolytics or primary angioplasty results in a long-term mortality reduction among individuals who have had a heart attack. The benefit of early reperfusion (less than 6 hours after the heart attack) was initially attributed to myocardial salvage and the resultant preservation of left ventricular function. However, it is now known that the survival benefit associated with thrombolytic therapy is not consistently associated with a major improvement in left ventricular ejection fraction (LVEF). These observations led to the formulation of the "late open artery hypothesis," which suggests that clinical outcomes can potentially be improved by late reperfusion after a heart attack. Observational clinical studies have suggested that late patency of the infarct-related artery (IRA) after thrombolysis is associated with a survival benefit that is independent of LVEF and therefore cannot be solely explained by salvage of myocardium. Definitive proof of the late open artery hypothesis is currently lacking, however, because previous studies that have evaluated late percutaneous transluminal coronary angioplasty (PTCA) of occluded IRAs after a heart attack have produced conflicting results.
These findings led to the organization of the Occluded Artery Trial (OAT), an international, NHLBI-funded, randomized trial of 2,200 participants. OAT is testing the hypothesis that mechanical reperfusion of an occluded IRA with PTCA and percutaneous coronary intervention (PCI) 3 to 28 days after a heart attack in high-risk individuals will reduce mortality, recurrent heart attacks, and hospitalization for class IV congestive heart failure. Enhancement of electrical stability is one of the major mechanisms that has been proposed to explain the association of an open IRA with an improved prognosis independent of myocardial salvage.
DESIGN NARRATIVE:
This study is an ancillary study of OAT. It will characterize the effects of late PCI of occluded IRAs on the most important and clinically relevant noninvasive markers of vulnerability to malignant ventricular arrhythmias: heart rate variability, T wave variability, and signal-averaged electrocardiography. These analyses will be performed in 300 participants at baseline, 30 days, and 1 year following a heart attack in order to determine the effects of late PCI on the autonomic nervous system, ventricular repolarization, and ventricular conduction abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCI+MED | Experimental | Procedure: PCI, Drug: Optimal Medical TherapyPercutaneous Coronary Intervention (PCI) with angioplasty and stenting of the infarct-related artery and optimal medical therapy |
| MED | Experimental | Drug: Optimal Medical TherapyOptimal medical therapy alone |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Has experienced a heart attack 3 to 28 days prior to study entry
- Persistently occluded IRA defined as either: 1) Thrombolysis in Myocardial Infarction (TIMI) 0, with no flow beyond the site of occlusion; or 2) TIMI 1, with penetration of dye beyond the site of occlusion without dye reaching the distal vessel
- LVEF less than 50% or proximal occlusion in a large vessel
- Normal sinus rhythm
- QRS duration less than 120 ms
Key exclusion criteria (9 listed)
- Has a clinical indication for revascularization (post-heart attack angina at rest; significant inducible ischemia; or significant left main or triple vessel disease requiring PTCA or CABG)
- Current serious illness or condition that limits 3-year survival
- Severe valvular disease
- Chronic total occlusion
- New York Heart Association Class III-IV congestive heart failure
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 |
|---|---|---|
| PCIAlso: Angioplasty and stenting of the infarct-related artery | Procedure or surgery | PCI+MED |
| Optimal Medical TherapyGuideline-directed drug therapies after MI | Drug | MED, PCI+MED |
Primary outcome
Short-termed Fractal Scaling Exponent (Alpha 1)
Time frame: Baseline, one year
Nonlinear measurement of heart rate variability, change between baseline and 1 year is the primary outcome.
2 secondary outcomes
T-wave Variability
Time frame: Baseline and one year
Filtered QRS Duration
Time frame: Baseline and one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15149425Rashba EJ. Assessment of ventricular repolarization abnormalities in congenital long QT syndrome. J Cardiovasc Electrophysiol. 2004 May;15(5):557-9. doi: 10.1046/j.1540-8167.2004.04022.x. No abstract available.
- Background: PubMed 15851311Rashba EJ. Should T-wave alternans testing be used to risk stratify candidates for prophylactic implantable cardioverter-defibrillator therapy? Heart Rhythm. 2005 Mar;2(3):242-4. doi: 10.1016/j.hrthm.2004.12.015. No abstract available.
- Results publication: PubMed 19188505Rashba EJ, Lamas GA, Couderc JP, Hollist SM, Dzavik V, Ruzyllo W, Fridrich V, Buller CE, Forman SA, Kufera JA, Carvalho AC, Hochman JS; OAT-EP Investigators. Electrophysiological effects of late percutaneous coronary intervention for infarct-related coronary artery occlusion: the Occluded Artery Trial-Electrophysiological Mechanisms (OAT-EP). Circulation. 2009 Feb 17;119(6):779-87. doi: 10.1161/CIRCULATIONAHA.108.808626. Epub 2009 Feb 2.
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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.
Eric J. Rashba, MD study chair
Stony Brook University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI and Optimal Medical Therapy in people with Cardiovascular Diseases and Heart Diseases, run by University of Maryland, Baltimore at 1 site in United States.
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 6 inclusion and 9 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 18 May 2022. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Short-termed Fractal Scaling Exponent (Alpha 1) (time frame: Baseline, one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00119847, which also lists 3 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 18 May 2022.