Examining heart function after temporary balloon blockage in coronary artery disease patients
STunning After Balloon Occlusion, A Single-center, Single-arm, Prospective Study
This study tests how well the heart works after temporarily blocking a coronary artery with a balloon in patients with stable coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT05023629 on ClinicalTrials.gov |
What this trial studies
This study investigates cardiac function and morphology following short-term coronary artery occlusion using balloon inflation in patients with stable coronary artery disease undergoing percutaneous coronary intervention. The primary objective is to assess how quickly regional myocardial function recovers after the occlusion. Additionally, the study aims to confirm through cardiac magnetic resonance imaging that no myocardial injury occurs post-occlusion and to develop a clinical model for studying myocardial stunning. The intervention involves the use of intracoronary balloon inflation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with stable coronary artery disease requiring percutaneous coronary intervention.
Not a fit: Patients with pre-existing heart failure or significant wall motion abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of myocardial recovery, potentially improving treatment strategies for patients with coronary artery disease.
How similar studies have performed: While this approach is novel in its specific focus, similar studies have shown promise in understanding myocardial function recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>18 years. 2. Stable CAD with indication for PCI of a lesion in either of the following coronary segments: 1. 6 or 7 (proximal or mid left anterior descending coronary artery) 2. 11 (Proximal left circumflex coronary artery) 3. 1 or 2 (proximal right coronary artery) 3. Normal cardiac function in the myocardial segments subtended by the target vessel, as assessed by echocardiography at the time of coronary angiography. 4. Written informed consent obtained. Exclusion Criteria: 1. Pre-existing heart failure 2. Known pre-existing irreversible regional or global wall motion abnormalities affecting the myocardial segments subtended by the target vessel. 3. Severe valvulopathy 4. Thrombolysis In Myocardial Infarction (TIMI) flow \<3 in the target vessel.
Where this trial is running
Gothenburg
- Kardiologen — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Björn Redfors — Sahlgrenska Universitetssjukhus
- Study coordinator: Björn Redfors, AssocProf
- Email: Bjoern.Redfors@wlab.gu.se
- Phone: +46 31 342 7543
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.