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NCT06854302Enrolling by invitation

Angina After PCI: a Systems Medicine Study

Angina After PCI: a Systems Medicine Cohort Study

Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Angina may persist or recur in patients treated by coronary angioplasty. The angioplasty involves a balloon treatment to open a blocked heart blood vessel and usually a stent (thin metal tube) is placed. Stents do not always improve symptoms and may make symptoms worse. Sometimes a drug-eluting-balloon is used instead of a stent. This balloon coats the inside of the blood vessel to prevent re-narrowing. Research is needed to clarify the causes of ongoing angina and its impact on patients and the NHS, and to identify which patients will or will not benefit from a stent (hence avoiding over-treatment in the future). We plan a 5-year UK-wide multicenter study involving up to 600 patients with angina undergoing coronary angioplasty (with or without a stent). They will initially have a heart MRI scan. We will assess what might influence the recurrence of angina in the year after the angioplasty procedure. We will measure small blood vessel function in the heart and the amount of plaque persisting after PCI. Patients who report angina after coronary angioplasty usually have a second invasive angiogram. Instead, we will invite patients to have a heart MRI scan allowing us to also assess whether this scan might be more useful than a repeat angiogram in guiding clinical care. We will collaborate with life scientists, mathematicians, statisticians, and health economists to better understand causes and health economic implications of angina arising after coronary angioplasty procedures.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
600 (estimated)
First submitted
24 Dec 2024
Start date
17 Sept 2024
Primary completion date
Sept 2027
Lead sponsor
NHS National Waiting Times Centre Board
NCT number
NCT06854302

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 17 Sept 2024 to the primary completion date, Sept 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age

  • Age \<=18 years

Other

  • Acute MI within 30 days
  • Invasive management \>90 days after stress CMR
  • Inability to comply with the protocol
  • Lack of written informed consent.
  • Pregnancy.

Who the study is looking for

  • BEFORE INVASIVE MANGEMENT
  • Angina by SAQ-7 Angina Frequency Score \<90\*
  • Stress CMR imaging\*
    • DURING INVASIVE MANAGEMENT
  • PCI (successful)
  • Coronary physiology assessment post-PCI.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Royal Papworth Hospital NHS Foundation Trust
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Golden Jubilee National Hospital
Coordinator of this site? Confirm its status
ClydebankUnited KingdomUnknown status
University Hospital Hairmyres
Coordinator of this site? Confirm its status
East KilbrideUnited KingdomUnknown status
Leeds General Infirmary
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.