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New treatment option for Percutaneous Coronary Intervention (PCI)
Official title Aerobic Exercise-induced Effect on Endothelial Function in Patients With Ischaemic Heart Disease
ClinicalTrials.gov ID: NCT06788275
What this study is testing
- What it's testing
- Endothelial dysfunction is one of the aetiological factors in ischaemic heart disease (IHD). Aerobic exercise is effective in improving endothelial function, as measured by flow-mediated dilation (FMD), in patients with IHD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 75
You may be able to join if
- Men and women aged between 45 and 75 years.
- Diagnosed with acute myocardial infarction, unstable or stable angina.
- Treated with percutaneous coronary intervention, coronary artery bypass grafting, or conservative treatment.
- Event or intervention within 3 to 12 months prior to participation in the study.
- Fluency in speaking and reading Spanish.
You likely can't join if
- Use of walking assistive devices.
- Treatment with chemotherapy for any type of cancer in the past 2 years.
- Hospitalisation in an intensive care unit in the past 6 months for reasons other than the ischaemic event.
- Acute myocardial infarction group IV Killip-Kimball.
- Obesity grade III (≥40.0 kg/m²).
- Medical contraindication for inclusion in an exercise programme.
See the full eligibility criteria
- Men and women aged between 45 and 75 years.
- Diagnosed with acute myocardial infarction, unstable or stable angina.
- Treated with percutaneous coronary intervention, coronary artery bypass grafting, or conservative treatment.
- Event or intervention within 3 to 12 months prior to participation in the study.
- Fluency in speaking and reading Spanish.
- Residing in Elche or surrounding areas and able to attend evaluations and the exercise programme (not planning to be absent for more than one week during the programme).
- Functional Class I-II according to the New York Heart Association (NYHA) classification.
- No physical limitations for exercise.
- Stable optimal medical treatment.
- Physically inactive, defined as 1) not meeting the World Health Organization recommendations for both aerobic and strength exercise, and 2) not participating in a structured exercise programme at least 3 days per week...
- Use of walking assistive devices.
- Treatment with chemotherapy for any type of cancer in the past 2 years.
- Hospitalisation in an intensive care unit in the past 6 months for reasons other than the ischaemic event.
- Acute myocardial infarction group IV Killip-Kimball.
- Obesity grade III (≥40.0 kg/m²).
- Medical contraindication for inclusion in an exercise programme.
- Diabetes with uncontrolled blood glucose levels.
- Poorly controlled hypertension: resting blood pressure \> 180/110 mmHg.
- Chest pain with exertion or ST-segment changes suggestive of residual ischemia during ergometry. Residual ischemia.
- Severely reduced functional capacity on initial ergometry (\<5 metabolic equivalent of task).
- Left ventricular ejection fraction less than 50%.
- Severe stenosis of the left main coronary artery (\>50% significant disease).
- Severe aortic stenosis, left ventricular outflow tract obstruction (e.g., obstructive hypertrophic cardiomyopathy) or aortic dissection.
- Severe valvulopathy.
- Acute pulmonary embolism or deep vein thrombosis.
- Severe pulmonary hypertension.
- Acute heart failure.
- Acute endocarditis, myocarditis, or pericarditis.
- Acute or chronic renal insufficiency (estimated glomerular filtration rate \<30 ml/min).
- Pulmonary fibrosis or interstitial disease (severe respiratory insufficiency or confirmed chronic obstructive pulmonary disease).
- Uncontrolled cardiac arrhythmias/hemodynamically unstable.
- Permanent or persistent/paroxysmal atrial fibrillation with episodes in the past 6 months.
- High-grade cardiac block.
- Presence of implantable devices: cardiac resynchronization therapy pacemaker, implantable cardioverter defibrillators, or pacemaker.
- Presence of ischaemic symptoms during the incremental exercise test performed before the intervention.
- Severe autonomic or peripheral neuropathy.
- Use of nitrates in pharmacological treatment.
- Any planned surgical or medical intervention during the study period.
- Plans to participate in or current participation in other studies that may interfere with this study.
- Current pregnancy or intention to become pregnant during the study period.
The study team makes the final eligibility decision.
Where it's taking place
- Alicante, Alicante, Spain
- Elche, Alicante, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alicante, Alicante, Spain; Elche, Alicante, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.