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NCT06676345: CAUTION 2
Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study
trial testing Surgical treatment in Ventricular Septal Defect in 800 participants. Currently enrolling.
31 December 2027
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 800 |
| Start date | 1 January 2025 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2032 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Surgical treatment
- Percutaneous treatment
Conditions studied
- Ventricular Septal Defect — all drugs for Ventricular Septal Defect →
- Papillary Muscle Rupture — all drugs for Papillary Muscle Rupture →
- Cardiac Rupture — all drugs for Cardiac Rupture →
- Pseudoaneurysm — all drugs for Pseudoaneurysm →
Sponsor
Maastricht University Medical Center
Who can join
18 and older, any sex, with Ventricular Septal Defect or Papillary Muscle Rupture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In 2019, the international study titled "CAUTION Study - 1" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on ClinicalTrials.gov (Identifier: NCT03848429). This study highlighted the outcomes of surgical treatment of post-infarction mechanical complications in patients operated between 2000 and 2019. Several scientific publications have resulted from this registry, which involved 27 international centers and recruited about 800 patients. However, retrospective studies are inherently limited by factors such as selection bias and a high number of missing data, affecting data interpretation and consistency of results. Moreover, most registries report only data about surgical patients or, in rare situations, about patients treated percutaneously. To overcome these limitations, a prospective study has been designed to collect more precise and focused data and achieve results that better reflect the current clinical practice, including all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned. "CAUTION Study - 2" is, therefore, a prospective, multicenter cohort study with the primary aim of analyzing the outcomes of surgical, percutaneous and conservative treatment of post-infarction mechanical complications in the contemporary era.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06676345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Ventricular Septal Defect
Currently open trials in the same condition.
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Other Maastricht University Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06676345 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 11 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06676345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing